Clinical Focus

  • Pathology

Academic Appointments

Administrative Appointments

  • Director, Transfusion Service Stanford Medical Center (2004 - Present)
  • Associate Director, Stanford Blood Center (2004 - Present)
  • Chair, School of Medicine Faculty Senate (2008 - 2010)
  • Chair, School of Medicine Faculty Senate Steering Committee (2008 - 2010)
  • Member, Committee on Performance, Professionalism, and Promotion Stanford University School of Medicine (2007 - 2011)
  • Member, Committee on Admissions, Stanford University School of Medicine (2008 - Present)

Professional Education

  • Board Certification: Blood Banking/Transfusion Medicine, American Board of Pathology (1987)
  • Fellowship:Case Western Reserve University School of Medicine (1981) OH
  • Residency:University of Alabama Hospital (1978) AL
  • Medical Education:University of Pennsylvania (1975) PA
  • Board Certification: Medical Oncology, American Board of Internal Medicine (1981)
  • Board Certification: Internal Medicine, American Board of Internal Medicine (1978)
  • Board Certification: Hematology, American Board of Internal Medicine (1980)
  • Internship:University of Alabama Hospital (1976) AL

Research & Scholarship

Current Research and Scholarly Interests

Dr. Goodnough has a long-standing interest in alternatives to blood therapy. This includes the concept of antologous blood predonation before elective surgery; acute normovolemic hermodicution;erythropoietic agents to stimulate red blood cell production; pharmacologic strategies to reduce blood loss; artificial oxygen carriers; and re-evaluation of the transfusion trigger. Publications: Goodnough LT: "Erythropoietin", In Scientific Basis of Transfusion Medicine (Anderson K and Ness P),WB Saunders Co, Phila. 1994;830-842. Lenes B, Goodnough LT: Educational aspects of transfusion medicine, In Quality Assurance in Transfusion Medicine: Conceptual, Serologic, and Microbiologic Aspects. (Rock G, Seghatchin MJ, eds.), CRC Press, Boca Raton, FCA, 1992;Ch 5:89-103. Goodnough LT, Geha AS: A new era in blood conservation (editorial). Ann Thor Surg 1991;51:703-704.99.Goodnough LT. Autologous blood donation and transfusion. In Technical Manual (Tyler V, ed) 13th Edition, American Association of Blood Banks, Bethesda, MD, 1999:111-126. Goodnough LT. Alternative strategies in platelet therapy. Transfusion Alternatives in Transfusion Medicine 1999;3:25-30. Goodnough LT. Platelet transfusion therapy. J Clin Apher 2001;16:43-48. Goodnough LT. Red cell support in the perioperative setting. In Rossi's Principles of Transfusion Medicine, 3rd Edition (Simon T, ed), Lippincott, Williams and Wilkins, Philadelphia, PA, 2002; 590-601. Goodnough LT. Book Review "Practical Transfusion Medicine" (Murphy MF, Pamphilon D, eds). Lancet 2001;58:251.145. Goodnough LT. Transfusion Medicine (Reply to Letter). N Engl J Med 2002;347:538-539.148. Goodnough LT. Autologous blood donation and transfusion. In Technical Manual (Brecher M, ed), 14th Edition, American Association of Blood Banks, Bethesda, MD, 2002; pp 105-126.149.Goodnough LT. Platelet and granulocyte antigens and antibodies. In Technical Manual (Brecher M, ed), 14th Edition, American Association of Blood Banks, Bethesda, MD, 2002; pp 341-360.171. Goodnough LT. Blood and blood conservation: A national perspective. 2003; J Cardiothor Vasc Anesth 2004; 18(5)65-115.


2014-15 Courses


Journal Articles

  • Infusion pump-mediated mechanical hemolysis in pediatric patients. Annals of clinical and laboratory science Hughes, J., McNaughton, J., Andrews, J., George, T., Bergero, C., Pyke-Grimm, K., Galel, S. A., Gonzalez, C., Goodnough, L. T., Fontaine, M. J. 2015; 45 (2): 140-147


    Hemoglobinuria was observed after packed red blood cell transfusion in a series of patients at our pediatric treatment center. Laboratory testing was suggestive of intravascular hemolysis with no support for an immunohematologic process.We investigated these adverse events to define a quality improvement plan and to prevent future hemolytic adverse events. Multiple factors were investigated, and the only change identified was the implementation of a new infusion pump (Pump A) that replaced a previous model (Pump B).In vitro pump analyses, a retrospective review of urinalyses, and prospective urinalysis and nursing surveillances were also performed.In in vitro analysis of the pumps, irradiated units with higher hematocrit at a low flow rate through Pump A had a greater than thirty-fold increase in free hemoglobin from baseline compared to minimal free hemoglobin changes seen with Pump B. Irradiated units with a lower hematocrit had a minimal change in free hemoglobin from baseline with both Pumps A and B at either low or high flow rate. Subsequently, only units with lower hematocrits were issued for transfusion of pediatric patients, and Pump A was replaced by Pump B in the outpatient unit. Retrospective and prospective surveillances found no additional unexplained cases of gross hemoglobinuria associated with transfusion.The investigation determined that infusion of higher hematocrit units using a specific commercial pump was associated with mechanical hemolysis. The change to units with lower hematocrit through an alternative pump has been an effective corrective action to date.

    View details for PubMedID 25887866

  • How I use fibrinogen replacement therapy in acquired bleeding BLOOD Levy, J. H., Goodnough, L. T. 2015; 125 (9): 1387-1393


    Fibrinogen is a critical protein for hemostasis and clot formation. However, transfusion guidelines have variable recommendations for maintaining fibrinogen levels in bleeding patients. An increasing number of studies support the practice of fibrinogen replacement therapy for acquired coagulopathies, and additional studies are underway. Fibrinogen therapy can be administered with cryoprecipitate or fibrinogen concentrates, and clinical practice varies according to their availability and licensing status. Fibrinogen concentrate therapy has been studied in animal models and clinical trials and supports the critical role of fibrinogen repletion in bleeding patients. Point-of-care testing will have an important role in guiding fibrinogen replacement for hemostatic therapy in clinical settings such as cardiovascular surgery, postpartum hemorrhage, and trauma. Fibrinogen therapy is an important component of a multimodal strategy for the treatment of coagulopathic bleeding.

    View details for DOI 10.1182/blood-2014-08-552000

    View details for Web of Science ID 000350820900010

    View details for PubMedID 25519751

  • Why Providers Transfuse Blood Products Outside Recommended Guidelines in Spite of Integrated Electronic Best Practice Alerts JOURNAL OF HOSPITAL MEDICINE Chen, J. H., Fang, D. Z., Goodnough, L. T., Evans, K. H., Porter, M. L., Shieh, L. 2015; 10 (1): 1-7

    View details for DOI 10.1002/jhm.2236

    View details for Web of Science ID 000347516300001

  • Cryoprecipitate therapy BRITISH JOURNAL OF ANAESTHESIA Nascimento, B., GOODNOUGH, L. T., Levy, J. H. 2014; 113 (6): 922-934


    Cryoprecipitate, originally developed as a therapy for patients with antihaemophilic factor deficiency, or haemophilia A, has been in use for almost 50 yr. However, cryoprecipitate is no longer administered according to its original purpose, and is now most commonly used to replenish fibrinogen levels in patients with acquired coagulopathy, such as in clinical settings with haemorrhage including cardiac surgery, trauma, liver transplantation (LT), or obstetric haemorrhage. Cryoprecipitate is a pooled product that does not undergo pathogen inactivation, and its administration has been associated with a number of adverse events, particularly transmission of blood-borne pathogens and transfusion-related acute lung injury. As a result of these safety concerns, along with emerging availability of alternative fibrinogen preparations, cryoprecipitate has been withdrawn from use in a number of European countries. Compared with the plasma from which it is prepared, cryoprecipitate contains a high concentration of coagulation factor VIII, coagulation factor XIII, and fibrinogen. Cryoprecipitate is usually licensed by regulatory authorities for the treatment of hypofibrinogenaemia, and recommended for supplementation when plasma fibrinogen levels decrease below 1 g litre(-1); however, this threshold is empiric and is not based on solid clinical evidence. Consequently, there is uncertainty over the appropriate dosing and optimal administration of cryoprecipitate, with some guidelines from professional societies to guide clinical practice. Randomized, controlled trials are needed to determine the clinical efficacy of cryoprecipitate, compared with the efficacy of alternative preparations. These trials will allow the development of evidence-based guidelines in order to inform physicians and guide clinical practice.

    View details for DOI 10.1093/bja/aeu158

    View details for Web of Science ID 000345822000007

    View details for PubMedID 24972790

  • The Next Chapter in Patient Blood Management Real-Time Clinical Decision Support AMERICAN JOURNAL OF CLINICAL PATHOLOGY Goodnough, L. T., Shah, N. 2014; 142 (6): 741-747
  • Restrictive blood transfusion practices are associated with improved patient outcomes TRANSFUSION Goodnough, L. T., Maggio, P., Hadhazy, E., Shieh, L., Hernandez-Boussard, T., Khari, P., Shah, N. 2014; 54 (10): 2753-2759

    View details for DOI 10.1111/trf.12723

    View details for Web of Science ID 000343821100023

  • Case report of a transfusion-associated hepatitis A infection TRANSFUSION Hughes, J. A., Fontaine, M. J., Gonzalez, C. L., Layon, A. G., Goodnough, L. T., Galel, S. A. 2014; 54 (9): 2202-2206

    View details for DOI 10.1111/trf.12648

    View details for Web of Science ID 000342141300011

  • Iron Deficiency Anemia-Bridging the Knowledge and Practice Gap TRANSFUSION MEDICINE REVIEWS Shander, A., Goodnough, L. T., Javidroozi, M., Auerbach, M., Carson, J., Ershler, W. B., Ghiglione, M., Glaspy, J., Lew, I. 2014; 28 (3): 156-166


    Despite its high prevalence, anemia often does not receive proper clinical attention, and detection, evaluation, and management of iron deficiency anemia and iron-restricted erythropoiesis can possibly be an unmet medical need. A multidisciplinary panel of clinicians with expertise in anemia management convened and reviewed recent published data on prevalence, etiology, and health implications of anemia as well as current therapeutic options and available guidelines on management of anemia across various patient populations and made recommendations on the detection, diagnostic approach, and management of anemia. The available evidence confirms that the prevalence of anemia is high across all populations, especially in hospitalized patients. Anemia is associated with worse clinical outcomes including longer length of hospital stay, diminished quality of life, and increased risk of morbidity and mortality, and it is a modifiable risk factor of allogeneic blood transfusion with its own inherent risks. Iron deficiency is usually present in anemic patients. An algorithm for detection and management of anemia was discussed, which incorporated iron study (with primary emphasis on transferrin saturation), serum creatinine and glomerular filtration rate, and vitamin B12 and folic acid measurements. Management strategies included iron therapy (oral or intravenous), erythropoiesis-stimulating agents, and referral as needed.

    View details for DOI 10.1016/j.tmrv.2014.05.001

    View details for Web of Science ID 000338905100006

    View details for PubMedID 24931617

  • Perioperative and transfusion outcomes in women undergoing cesarean hysterectomy for abnormal placentation TRANSFUSION Brookfield, K. F., Goodnough, L. T., Lyell, D. J., Butwick, A. J. 2014; 54 (6): 1530-1536


    Women with placenta increta (PI) and placenta percreta (PP) are at high risk of obstetric hemorrhage; however, the severity of hemorrhage and perioperative morbidity may differ according to the degree of placental invasion. We sought to compare blood component usage and perioperative morbidity between women with PI versus PP undergoing cesarean hysterectomy (CH).We identified 77 women who underwent CH for PI or PP from the NICHD MFMU Network Cesarean Registry, which sourced data from 19 centers from 1999 to 2002. We examined demographic, obstetric, and surgical data and rates of transfusion and perioperative morbidity. We performed statistical tests for between-group analyses; p values less than 0.05 were significant.Rates of intraoperative or postoperative red blood cell (RBC) transfusion were similar between groups (PI 84% vs. PP 88%; p = 0.7). We observed no between-group differences in rates of fresh-frozen plasma (FFP) transfusion (intraoperative FFP-PI 30% vs. PP 41%; p = 0.3; postoperative FFP-PI 28% vs. PP 18%; p = 0.4) or platelet (PLT) transfusion (intraoperative PLTs-PI 14% vs. PP 29%; p = 0.2; postoperative PLTs-PI 9% vs. PP 9%; p = 1.0). Among the morbidities, a higher proportion of PP women underwent cystotomy (PI 14% vs. PP 38%; p = 0.02) and postoperative mechanical ventilation (PI 14% vs. PP 35%; p = 0.03).Rates of intraoperative RBC, FFP, and PLT transfusion are similar for PI and PP women, and perioperative outcomes are worse for PP women. We suggest the same mobilization transfusion medicine support for both groups, including blood ordering (type and cross-match for CH) and availability of emergency blood protocols including fibrinogen-containing preparations.

    View details for DOI 10.1111/trf.12483

    View details for Web of Science ID 000337591200015

    View details for PubMedID 24188691

  • In reply. Transfusion Levy, J. H., Goodnough, L. T. 2014; 54 (5): 1443-1444

    View details for DOI 10.1111/trf.12604

    View details for PubMedID 24819079

  • Improved blood utilization using real-time clinical decision support TRANSFUSION Goodnough, L. T., Shieh, L., Hadhazy, E., Cheng, N., Khari, P., Maggio, P. 2014; 54 (5): 1358-1365


    We analyzed blood utilization at Stanford Hospital and Clinics after implementing real-time clinical decision support (CDS) and best practice alerts (BPAs) into physician order entry (POE) for blood transfusions.A clinical effectiveness (CE) team developed consensus with a suggested transfusion threshold of a hemoglobin (Hb) level of 7 g/dL, or 8 g/dL for patients with acute coronary syndromes. The CDS was implemented in July 2010 and consisted of an interruptive BPA at POE, a link to relevant literature, and an "acknowledgment reason" for the blood order.The percentage of blood ordered for patients whose most recent Hb level exceeded 8 g/dL ranged at baseline from 57% to 66%; from the education intervention by the CE team August 2009 to July 2010, the percentage decreased to a range of 52% to 56% (p = 0.01); and after implementation of CDS and BPA, by end of December 2010 the percentage of patients transfused outside the guidelines decreased to 35% (p = 0.02) and has subsequently remained below 30%. For the most recent interval, only 27% (767 of 2890) of transfusions occurred in patients outside guidelines. Comparing 2009 to 2012, despite an increase in annual case mix index from 1.952 to 2.026, total red blood cell (RBC) transfusions decreased by 7186 units, or 24%. The estimated net savings for RBC units (at $225/unit) in purchase costs for 2012 compared to 2009 was $1,616,750.Real-time CDS has significantly improved blood utilization. This system of concurrent review can be used by health care institutions, quality departments, and transfusion services to reduce blood transfusions.

    View details for DOI 10.1111/trf.12445

    View details for Web of Science ID 000335634700024

  • Fibrinogen as a therapeutic target for bleeding: a review of critical levels and replacement therapy TRANSFUSION Levy, J. H., Welsby, I., Goodnough, L. T. 2014; 54 (5): 1389-1405


    Fibrinogen plays a critical role in achieving and maintaining hemostasis and is fundamental to effective clot formation. There is increasing awareness of the important role of fibrinogen as a key target for the treatment and prevention of acquired bleeding. Fibrinogen is the first coagulation factor to fall to critically low levels (<1.0 g/L) during major hemorrhage (normal plasma fibrinogen levels range from 2.0 to 4.5 g/L), and current guidelines recommend maintaining the plasma fibrinogen level above 1.5 g/L. Fibrinogen supplementation can be achieved using plasma or cryoprecipitate; however, there are a number of safety concerns associated with these allogeneic blood products and there is a lack of high-quality evidence to support their use. Additionally, there is sometimes a long delay associated with the preparation of frozen products for infusion. Fibrinogen concentrate provides a promising alternative to allogeneic blood products and has a number of advantages: it allows a standardized dose of fibrinogen to be rapidly administered in a small volume, has a very good safety profile, and is virally inactivated as standard. Administration of fibrinogen concentrate, often guided by point-of-care viscoelastic testing to allow individualized dosing, has been successfully used as hemostatic therapy in a range of clinical settings, including cardiovascular surgery, postpartum hemorrhage, and trauma. Results show that fibrinogen concentrate is associated with a reduction or even total avoidance of allogeneic blood product transfusion. Fibrinogen concentrate represents an important option for the treatment of coagulopathic bleeding; further studies are needed to determine precise dosing strategies and thresholds for fibrinogen supplementation.

    View details for DOI 10.1111/trf.12431

    View details for Web of Science ID 000335634700028

    View details for PubMedID 24117955

  • Experience with intravenous ferric carboxymaltose in patients with iron deficiency anemia. Therapeutic advances in hematology Bregman, D. B., Goodnough, L. T. 2014; 5 (2): 48-60


    Erythropoiesis may be limited by absolute or functional iron deficiency or when chronic inflammatory conditions lead to iron sequestration. Intravenous iron may be indicated when oral iron cannot address the deficiency. Ferric carboxymaltose (FCM) is a nondextran iron preparation recently approved in the United States for intravenous treatment of iron deficiency anemia (IDA) in adult patients with intolerance or unsatisfactory response to oral iron or with nondialysis-dependent chronic kidney disease. The full dose is two administrations of up to 750 mg separated by at least 7 days (up to 1500 mg total). FCM can be injected in 7-8 min or diluted in saline for slower infusion. The efficacy and safety of this dose was established in two prospective trials that randomized over 3500 subjects, 1775 of whom received FCM. One trial showed similar efficacy of FCM to an approved intravenous iron regimen (1000 mg of iron sucrose) in 2500 subjects with chronic kidney disease and additional cardiovascular risk factors. The other trial showed superior efficacy of FCM to oral iron in subjects with IDA due to various etiologies (e.g. gastrointestinal or uterine bleeding). In these trials, there was no significant difference between FCM and comparator with respect to an independently adjudicated composite safety endpoint, including death, myocardial infarction, or stroke. A database of 5799 subjects exposed to FCM provided a safety profile acceptable for regulatory approval. Mechanistic studies demonstrated that the transient, asymptomatic reduction in serum phosphate observed following FCM administration results from induction of fibroblast growth factor 23, which in turn induces renal phosphate excretion. An elevated hepcidin level may identify patients with IDA who will not respond to oral iron but will respond to FCM. The ability to administer FCM in two rapid injections or infusions will likely be viewed favorably by patients and healthcare providers.

    View details for DOI 10.1177/2040620714521127

    View details for PubMedID 24688754

  • Ferric carboxymaltose in patients with iron-deficiency anemia and impaired renal function: the REPAIR-IDA trial NEPHROLOGY DIALYSIS TRANSPLANTATION Onken, J. E., Bregman, D. B., Harrington, R. A., Morris, D., Buerkert, J., Hamerski, D., Iftikhar, H., Mangoo-Karim, R., Martin, E. R., Martinez, C. O., Newman, G. E., Qunibi, W. Y., Ross, D. L., Singh, B., Smith, M. T., Butcher, A., Koch, T. A., Goodnough, L. T. 2014; 29 (4): 833-842


    Iron-deficiency anemia in non-dialysis-dependent chronic kidney disease (NDD-CKD) frequently requires parenteral iron replacement, but existing therapies often require multiple administrations. We evaluated the efficacy and cardiovascular safety of ferric carboxymaltose (FCM), a non-dextran parenteral iron permitting large single-dose infusions, versus iron sucrose in patients with iron-deficiency anemia and NDD-CKD.A total of 2584 participants were randomized to two doses of FCM 750 mg in one week, or iron sucrose 200 mg administered in up to five infusions in 14 days. The primary efficacy endpoint was the mean change to highest hemoglobin from baseline to Day 56. The primary composite safety endpoint included all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, unstable angina, congestive heart failure, arrhythmias and hyper- and hypotensive events.The mean hemoglobin increase was 1.13 g/dL in the FCM group and 0.92 g/dL in the iron sucrose group (95% CI, 0.13-0.28). Similar results were observed across all subgroups, except Stage 2 CKD. More subjects in the FCM group achieved a hemoglobin increase of ≥ 1.0 g/dL between baseline and Day 56 (48.6 versus 41.0%; 95% CI, 3.6-11.6%). There was no significant difference between FCM and iron sucrose recipients with respect to the primary composite safety endpoint, including the major adverse cardiac events of death, myocardial infarction, or stroke. A significant difference in the number of protocol-defined, predominantly transient hypertensive episodes was observed in the FCM group.Two 750-mg infusions of FCM are a safe and effective alternative to multiple lower dose iron sucrose infusions in NDD-CKD patients with iron-deficiency anemia.

    View details for DOI 10.1093/ndt/gft251

    View details for Web of Science ID 000336093700020

    View details for PubMedID 23963731

  • Iron-related adverse effects from stored blood BLOOD Goodnough, L. T. 2014; 123 (9): 1287-1289

    View details for DOI 10.1182/blood-2014-01-547620

    View details for Web of Science ID 000335839300006

    View details for PubMedID 24578494

  • Open aortic valve replacement in a patient with Glanzmann's thrombasthenia: a multidisciplinary strategy to minimize perioperative bleeding TRANSFUSION Sheikh, A. Y., Hill, C. C., Goodnough, L. T., Leung, L. L., Fischbein, M. P. 2014; 54 (2): 300-305


    BACKGROUND: Glanzmann thrombasthenia (GT) is an autosomal recessive disorder in which the platelet (PLT) glycoprotein IIb/IIIa complex is either deficient or dysfunctional. In its most severe form, GT may result in spontaneous bleeding, although most cases are first detected in the setting of an invasive procedure. CASE REPORT: A 59-year-old male with Type I GT and a history of transfusion reactions to PLT infusions developed severe aortic stenosis secondary to bicuspid valve disease. He successfully underwent open aortic valve replacement with cardiopulmonary bypass without perioperative bleeding complications. RESULTS: A multidisciplinary team (anesthesia, hematology, cardiac surgery, and transfusion medicine) was established to optimize perioperative hematologic management. Bleeding risk was assessed given the patient's prior history and a dosing timeline for administration of blood products and recombinant clotting factors was established. Successful management was achieved during the operation by prophylactic administration of HLA-matched PLTs and Factor VIIa. Prophylactic PLT administration was continued through the immediate postoperative period and no bleeding complications occurred. Thromboelastograms (TEGs) were used in conjunction with traditional hematologic laboratory analysis to optimize clinical management. CONCLUSION: Patients with GT requiring cardiac surgical procedures are at high risk for perioperative bleeding complications. This case report illustrates the importance of multidisciplinary planning, TEG analysis, and the judicious use of recombinant factors to minimize operative bleeding risk.

    View details for DOI 10.1111/trf.12275

    View details for Web of Science ID 000331382100009

  • Successful treatment of recurrent hyperhemolysis syndrome with immunosuppression and plasma-to-red blood cell exchange transfusion TRANSFUSION Uhlmann, E. J., Shenoy, S., Goodnough, L. T. 2014; 54 (2): 384-388


    BACKGROUND: Hyperhemolysis syndrome is a serious transfusion reaction mostly reported in association with sickle cell disease, characterized by destruction of both donor and host red blood cells (RBCs) by an unknown mechanism. CASE REPORT: A 21-year-old man with sickle cell disease and multiple prior transfusions received two phenotype-matched, compatible RBC units during a brief admission for pain crisis. He developed rapid-onset progressive anemia and hemoglobinuria. Methylprednisolone, erythropoietin, and rituximab were administered. Fifteen days posttransfusion the hemoglobin (Hb) concentration decreased to 3.1 g/dL, with evidence of severe congestive heart failure. No new antibodies were identified. It was felt that his heart failure would not improve without increasing oxygen-carrying capacity. A combination of volume overload, anemia, and hemolysis prompted a novel isovolemic procedure to increase Hb level without removing his own RBCs or causing fluid overload. A cell separator was used operating on the plasma-exchange program, with three cross-match-compatible, washed RBC units as the replacement fluid. After the procedure, there was no evidence of hemolysis. Over the following 6 days, the congestive heart failure resolved, the Hb concentration increased to 7.5 g/dL, and the patient fully recovered. He had a similar event 3 years previously. CONCLUSIONS: Plasma-to-RBC replacement may be beneficial for selected patients with life-threatening anemia. This intervention provides immediate improvement in oxygen-carrying capacity, conserving the patient's own RBCs, while avoiding fluid overload. Although blood transfusion may precipitate further hemolysis, this case report describes successful plasma-to-RBC exchange transfusion with concurrent supportive care to offset hemolysis, including corticosteroid, intravenous immunoglobulin, and rituximab.

    View details for DOI 10.1111/trf.12258

    View details for Web of Science ID 000331382100018

    View details for PubMedID 23692505

  • A multicenter, randomized, active-controlled study to investigate the efficacy and safety of intravenous ferric carboxymaltose in patients with iron deficiency anemia TRANSFUSION Onken, J. E., Bregman, D. B., Harrington, R. A., Morris, D., Acs, P., Akright, B., Barish, C., Bhaskar, B. S., Smith-Nguyen, G. N., Butcher, A., Koch, T. A., Goodnough, L. T. 2014; 54 (2): 306-315


    BACKGROUND: Many patients receiving oral iron for iron deficiency anemia (IDA) cannot tolerate or fail to respond to therapy, and existing intravenous (IV) iron formulations often require repeated administrations. Ferric carboxymaltose (FCM), a nondextran IV formulation, permits larger single doses. STUDY DESIGN AND METHODS: We evaluated FCM versus oral iron in IDA patients. After 14 days of oral iron, 507 participants responding inadequately to oral iron (hemoglobin [Hb] increase <1 g/dL; Cohort 1) were assigned to Group A (two doses of FCM, 750 mg, 1 week apart) or Group B (oral iron, 325 mg, 3 × day for 14 additional days). Also, 504 subjects not appropriate for oral iron (Cohort 2) were assigned to Group C (FCM as above) or Group D (standard-of-care IV iron). The primary efficacy endpoint was change to highest observed Hb from baseline to Day 35. The composite safety endpoint included all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, unstable angina, heart failure, arrhythmias, and hyper- or hypotensive events. RESULTS: Mean (± standard deviation [SD]) Hb increase was significantly greater in Group A-FCM than Group B-oral iron: 1.57 (±1.19) g/dL versus 0.80 (±0.80) g/dL (p = 0.001). Post hoc comparison of Group C-FCM and Group D-IV standard of care also demonstrated significant mean (±SD) increase in Hb from baseline to highest value by Day 35 in Group C versus Group D: 2.90 (±1.64) g/dL versus 2.16 (±1.25) g/dL (p = 0.001). Safety endpoints occurred in 17 of 499 (3.4%) participants receiving FCM versus 16 of 498 (3.2%) in comparator groups. CONCLUSION: Two 750-mg FCM infusions are safe and superior to oral iron in increasing Hb levels in IDA patients with inadequate oral iron response.

    View details for DOI 10.1111/trf.12289

    View details for Web of Science ID 000331382100010

    View details for PubMedID 23772856

  • Blood utilization and hemoglobin levels in cancer patients after label and coverage changes for erythropoiesis-stimulating agents. Expert review of hematology Xu, H., Kaye, J. A., Saltus, C. W., Crawford, J., Gasal, E., Goodnough, L. T. 2014: 1-17


    A comprehensive literature search was performed to examine the influence of changes in erythropoietin-stimulating agent (ESA) label and reimbursement policies on utilization of red blood cell transfusions and patient hemoglobin levels in US cancer patients receiving chemotherapy or anemia management. Studies conducted in ESA-treated patients showed an increase in transfusion rates when comparing the post-intervention period with pre-intervention period (range of relative change: 15-125%). Results from studies conducted in patients receiving chemotherapy irrespective of anemia treatment were variable; single-institution-based studies tended to show a decrease in transfusion rates (range of relative change: -3.2 to -24.1%), while multiple-institution-based studies suggested an increase in transfusion rates (range of relative change: 12-182%). Studies showed decreases in hemoglobin levels during chemotherapy or at ESA initiation, and decreased ESA utilization.

    View details for DOI 10.1586/17474086.2014.943730

    View details for PubMedID 25081548

  • Evaluation and management of anemia in the elderly AMERICAN JOURNAL OF HEMATOLOGY Goodnough, L. T., Schrier, S. L. 2014; 89 (1): 88-96


    Anemia is now recognized as a risk factor for a number of adverse outcomes in the elderly, including hospitalization, morbidity, and mortality. What constitutes appropriate evaluation and management for an elderly patient with anemia, and when to initiate a referral to a hematologist, are significant issues. Attempts to identify suggested hemoglobin levels for blood transfusion therapy have been confounded for elderly patients with their co-morbidities. Since no specific recommended hemoglobin threshold has stood the test of time, prudent transfusion practices to maintain hemoglobin thresholds of 9-10 g/dL in the elderly are indicated, unless or until evidence emerges to indicate otherwise. Am. J. Hematol. 89:88-96, 2014. © 2013 Wiley Periodicals, Inc.

    View details for DOI 10.1002/ajh.23598

    View details for Web of Science ID 000330093900015

    View details for PubMedID 24122955

  • Can Blood Transfusion Be Not Only Ineffective, But Also Injurious? ANNALS OF THORACIC SURGERY Shander, A., Goodnough, L. T. 2014; 97 (1): 11-14
  • Case report of a transfusion-associated hepatitis A infection. Transfusion Hughes, J. A., Fontaine, M. J., Gonzalez, C. L., Layon, A. G., Goodnough, L. T., Galel, S. A. 2014


    Documented transfusion-associated hepatitis A (TAHA) is rare, and blood donors in the United States are not routinely screened for this infection. We report a case of TAHA associated with a donation made 8 days after a donor returned from a trip to South America.This is a review of donor and recipient records and a review of the literature.A donor developed symptoms of hepatitis 20 days after donation (28 days after returning from South America). The donor reported the illness 56 days after donation when contacted to schedule another visit. By this time, the red blood cell and frozen plasma components had been transfused. The recipient of the plasma, a 15-month-old female, tested positive for immunoglobulin M antibody to hepatitis A virus 43 days after transfusion. The recipient had displayed mild, nonspecific symptoms approximately 2 weeks after transfusion. Hospital infection control investigated the potential for further spread within the hospital because the recipient had been an inpatient for most of the posttransfusion period. The risk of transmission to other patients was determined to be negligible because the patient had been in isolation for other reasons. Family members, who included a health care professional, were counseled and offered prophylaxis.TAHA may be underrecognized. This case was identified only because of a donor report at the time of recruitment. Asymptomatic donor viremia has been documented in plasma donors. Although TAHA rarely results in severe disease, the risk it creates of secondary transmission especially within the hospital setting is not inconsequential.

    View details for DOI 10.1111/trf.12648

    View details for PubMedID 24689888

  • Restrictive blood transfusion practices are associated with improved patient outcomes. Transfusion Goodnough, L. T., Maggio, P., Hadhazy, E., Shieh, L., Hernandez-Boussard, T., Khari, P., Shah, N. 2014


    Blood transfusion has been cited as one of the five most overutilized therapeutic procedures in the United States. We assessed the impact of clinical decision support at computerized physician order entry and education on red blood cell (RBC) transfusions and clinical patient outcomes at our institution.Clinical patient outcomes and RBC transfusions were assessed before and after implementation of a best practice alert triggered for transfusions when the hemoglobin level was higher than 7 g/dL for all inpatient discharges from January 2008 through December 2013. Retrospective clinical and laboratory data related to RBC transfusions were extracted: case-mix complexity, patient discharges and selected surgical volumes, and patient outcomes (mortality, 30-day readmissions, length of stay).There was a significant improvement in RBC utilization as assessed by RBC units transfused per 100 patient-days-at-risk. Concurrently, hospital-wide clinical patient outcomes showed improvement (mortality, p = 0.034; length of stay, p = 0.003) or remained stable (30-day readmission rates, p = 0.909). Outcome improvements were even more pronounced in patients who received blood transfusions, with decreased mortality rate (55.2 to 33.0, p < 0.001), length of stay (mean, 10.1 to 6.2 days, p < 0.001), and 30-day readmission rate (136.9 to 85.0, p < 0.001). The mean number of units transfused per patient also declined (3.6 to 2.7, p < 0.001). Acquisition costs of RBC units per 1000 patient discharges decreased from $283,130 in 2009 to $205,050 in 2013 with total estimated savings of $6.4 million and likely far greater impact on total transfusion-related costs.Improved blood utilization is associated with improved clinical patient outcomes.

    View details for DOI 10.1111/trf.12723

    View details for PubMedID 24995770

  • Does Plasma Transfusion Therapy Have a Role in Clinical Medicine? CRITICAL CARE MEDICINE Goodnough, L. T. 2013; 41 (8): 2041-2042

    View details for DOI 10.1097/CCM.0b013e31828fd93b

    View details for Web of Science ID 000325701500045

    View details for PubMedID 23863240

  • Concepts of blood transfusion in adults. Lancet Goodnough, L. T., Levy, J. H., Murphy, M. F. 2013; 381 (9880): 1845-1854


    Recent progress has been made in the identification and implementation of best transfusion practices on the basis of evidence-based clinical trials, published clinical practice guidelines, and process improvements for blood use and clinical patient outcomes. However, substantial variability persists in transfusion outcomes for patients in some clinical settings--eg, patients undergoing cardiothoracic surgery. This variability could be the result of insufficient understanding of published guidelines; different recommendations of medical societies, including the specification of a haemoglobin concentration threshold to use as a transfusion trigger; the value of haemoglobin as a surrogate indicator for transfusion benefit, even though only changes in concentration and not absolute red cell mass of haemoglobin can be identified; and disagreement about the validity of the level 1 evidence for clinical practice guidelines. Nevertheless, institutional experience and national databases suggest that a restrictive blood transfusion approach is being increasingly implemented as best practice.

    View details for DOI 10.1016/S0140-6736(13)60650-9

    View details for PubMedID 23706801

  • Alternatives to blood transfusion LANCET Spahn, D. R., Goodnough, L. T. 2013; 381 (9880): 1855-1865


    The use of alternatives to allogeneic blood continues to rest on the principles that blood transfusions have inherent risks, associated costs, and affect the blood inventory available for health-care delivery. Increasing evidence exists of a fall in the use of blood because of associated costs and adverse outcomes, and suggests that the challenge for the use of alternatives to blood components will similarly be driven by costs and patient outcomes. Additionally, the risk-benefit profiles of alternatives to blood transfusion such as autologous blood procurement, erythropoiesis-stimulating agents, and haemostatic agents are under investigation. Nevertheless, the inherent risks of blood, along with the continued rise in blood costs are likely to favour the continued development and use of alternatives to blood transfusion. We summarise the current roles of alternatives to blood in the management of medical and surgical anaemias.

    View details for Web of Science ID 000319443700032

    View details for PubMedID 23706802

  • Blood management: transfusion medicine comes of age. Lancet Goodnough, L. T. 2013; 381 (9880): 1791-1792

    View details for DOI 10.1016/S0140-6736(13)60673-X

    View details for PubMedID 23706789

  • Logistics of transfusion support for patients with massive hemorrhage CURRENT OPINION IN ANESTHESIOLOGY Goodnough, L. T., Spain, D. A., Maggio, P. 2013; 26 (2): 208-214


    Traditionally, trauma resuscitation protocols have advocated sequential administration of therapeutic components, beginning with crystalloid solutions infused to replace lost intravascular volume. However, rapid restoration of the components of blood is essential for ensuring adequate tissue perfusion and for preventing acidosis, coagulopathy, and hypothermia, referred to as the 'lethal triad' in trauma settings. The review summarizes practical approaches for transfusion support of patients with massive hemorrhage.Massive transfusion protocols for blood transfusion support are reviewed, including practical considerations from our own. We maintain an inventory of thawed, previously frozen plasma (four units each of blood group O and A), which can be issued immediately for patients in whom the blood type is known. As frozen plasma requires 45 min to thaw, liquid AB plasma (26 day outdate) functions as an excellent alternative, particularly for patients with unknown or blood group B or AB types.Close monitoring of bleeding and coagulation in trauma patients allows goal-directed transfusions to optimize patients' coagulation, reduce exposure to blood products, and to improve patient outcomes. Future studies are needed to understand and demonstrate improved patient outcomes.

    View details for DOI 10.1097/ACO.0b013e32835d6f8f

    View details for Web of Science ID 000316310800018

  • Transfusion outcomes in patients undergoing coronary artery bypass grafting treated with prasugrel or clopidogrel: TRITON-TIMI 38 retrospective data analysis JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY Goodnough, L. T., Smith, P. K., Levy, J. H., Poston, R. S., Short, M. A., Weerakkody, G. J., LeNarz, L. A. 2013; 145 (4): 1077-?


    Coronary artery bypass grafting-related bleeding and associated transfusion is a concern with dual antiplatelet therapy in patients with acute coronary syndromes. The objective of the present study was to characterize a potential risk-adjusted difference in transfusion requirements between prasugrel and clopidogrel cohorts.The data from 422 patients undergoing isolated coronary artery bypass grafting from the TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet InhibitioN with prasugrel Thrombolysis In Myocardial Infarction 38 were analyzed retrospectively.We found no difference in baseline transfusion risk scores between cohorts. As predicted, the number of units of red blood cells transfused perioperatively correlated with the transfusion risk score (P < .0001). Overall, the 12-hour chest tube drainage volumes and platelet transfusion rates in the prasugrel cohort were significantly greater. However, no statistically significant differences were found in the number of red blood cell transfusions, total hemostatic components transfused, or total blood donor exposure. A significantly greater number of platelet units were transfused postoperatively in the prasugrel patients who underwent surgery within 5 days or less after withdrawal of drug. In an analysis adjusted for the predicted risk of mortality, total donor exposure was not associated with increased mortality.The use of prasugrel compared with clopidogrel was associated with greater 12-hour chest tube drainage volumes and platelet transfusion rates but without any significant differences in red blood cell transfusions, total hemostatic components transfused, or total blood donor exposure.

    View details for DOI 10.1016/j.jtcvs.2012.07.059

    View details for Web of Science ID 000316753100029

    View details for PubMedID 22995726

  • Update on erythropoiesis-stimulating agents. Best practice & research. Clinical anaesthesiology Goodnough, L. T., Shander, A. 2013; 27 (1): 121-129


    Erythropoiesis-stimulating agents (ESAs) have long been approved for the management of anaemia in a variety of clinical settings. Subsequently, a number of clinical trials were undertaken in which the haemoglobin end points were targeted to be maintained at normal or high-normal ranges, in an attempt to demonstrate improvements in long-term survival. For patients undergoing spine surgery, patients with cancer chemotherapy-induced anaemia and those with chronic kidney disease, adverse outcomes in these clinical trials were found, including death, thrombosis and/or cardiovascular events. Informed choice by patients for risks of ESA therapy as well as for blood transfusion should be part of the consent process for management of anaemia. Despite current regulations restricting ESA use, these agents are an effective treatment of anaemia, particularly for those who would be transfusion dependent without ESA therapy.

    View details for DOI 10.1016/j.bpa.2012.11.006

    View details for PubMedID 23590921

  • Iron: the new advances in therapy. Best practice & research. Clinical anaesthesiology Auerbach, M., Goodnough, L. T., Shander, A. 2013; 27 (1): 131-140


    Conditions known as iron-deficiency syndromes are very common in various patient populations, and they can adversely affect the outcomes of the patients, in addition to increasing their risk of getting transfused. Iron-deficiency syndromes include absolute iron deficiency (absence of storage iron), functional iron deficiency (when demand for iron exceeds the supply in face of intense stimulation erythropoiesis) and iron sequestration (in which existing storage iron becomes unavailable); these conditions often co-exist in hospitalised patients, making the diagnosis and management more difficult. Nonetheless, iron is emerging as a safe and effective therapy in patients suffering from these conditions. Notably, several intravenous iron formulations are available and they can be used safely and effectively to restore the body iron levels (possibly even in a single treatment episode). Data from ongoing clinical trials are expected to further establish the role of these products in treatment of patients with anaemia.

    View details for DOI 10.1016/j.bpa.2012.12.001

    View details for PubMedID 23590922

  • Hepcidin levels predict nonresponsiveness to oral iron therapy in patients with iron deficiency anemia AMERICAN JOURNAL OF HEMATOLOGY Bregman, D. B., Morris, D., Koch, T. A., He, A., Goodnough, L. T. 2013; 88 (2): 97-101


    Levels of hepcidin, a major regulator of iron homeostasis, may identify patients with iron deficiency anemia (IDA) who will not respond to oral iron therapy. In this study, IDA patients underwent a 14-day trial (run-in) course of ferrous sulfate therapy. Nonresponders (Hgb increase <1 g/dL with 67% compliance rate) were randomized to IV ferric carboxymaltose (FCM; two injections of 750 mg) or further oral iron for 14 days. Screening hepcidin levels were 38.4 versus 11.3 ng/mL, P = 0.0002 in nonresponders versus responders to a trial of oral iron. Hepcidin of > 20 ng/mL, showed sensitivity of 41.3%, specificity of 84.4%, and positive predictive value of 81.6% for predicting nonresponsiveness to oral iron. PPVs for ferritin> 30 ng/mL or transferrin saturation (TSAT)>15% were 59.2 and 55%, respectively. Negative predictive values for hepcidin, ferritin, and TSAT were 46.3, 22.7, and 19.7, respectively. FCM versus oral iron showed Hgb increases of ≥ 1 gm/dL in 65.3% versus 20.8% (P < 0.0001) and Hgb increases of 1.7 ± 1.3 versus 0.6 ± 0.9 g/dL (P = 0.0025), respectively. We conclude that hepcidin predicts nonresponsiveness to oral iron in patients with IDA and is superior to TSAT or ferritin for this purpose. Nonresponse to oral iron therapy does not rule out IDA, since two-thirds of patients subsequently responded to intravenous iron.

    View details for DOI 10.1002/ajh.23354

    View details for Web of Science ID 000314149700003

    View details for PubMedID 23335357

  • In reply. Anesthesiology Goodnough, L. T., Shander, A. 2013; 118 (1): 223-224

    View details for DOI 10.1097/ALN.0b013e318276c2c8

    View details for PubMedID 23249936

  • Blood ordering from the operating room: turnaround time as a quality indicator TRANSFUSION McClain, C. M., Hughes, J., Andrews, J. C., Blackburn, J., Sephel, S., France, D., Viele, M., Goodnough, L. T., Young, P. P. 2013; 53 (1): 41-48


    Quality indicators in transfusion medicine are necessary for patient safety and customer satisfaction. The turnaround time (TAT) of issuing red blood cells (RBCs) has emerged as a quality indicator but is not an established benchmark. We examined the TAT for issuing RBCs from the blood bank to the operating rooms (ORs) at Vanderbilt University Medical Center (VUMC) and Stanford University Medical Center (SUMC).TAT was defined from time of request to when RBCs exited the blood bank. Cases eligible for analysis had completed type-and-screen results with requests for four or fewer RBC units. Patients with a positive antibody screen had serologically crossmatched units prepared and reserved for intraoperative use. We also e-mailed surveys to academic institutions to establish the current state of TAT monitoring and to anesthesiologists at VUMC to gauge the TAT expectations of the OR.The mean TATs at the two institutions were comparable (VUMC, 10 ± 3.8 min; SUMC, 14 ± 7.2 min) for orders of RBCs. The most common reasons for delayed TAT were overlapping orders, medical technologists occupied by phone calls, and oversaturation of pneumatic tube stations. Only 3 of 24 surveyed institutions actively monitored RBC TAT. Surveyed anesthesiologists (n = 7) reported an expectation for RBC TAT of 5 to 15 minutes for urgent cases. Established internal TAT policies were 15 and 20 minutes at VUMC and SUMC, respectively, for crossmatched RBC requests for patients with complete diagnostic testing.Many of the surveyed institutions do not monitor stat RBC issue TAT as a quality indicator. This study serves as a starting point for establishing a benchmark for TAT for issuing RBCs from the blood bank to ORs.

    View details for DOI 10.1111/j.1537-2995.2012.03670.x

    View details for Web of Science ID 000313348900009

    View details for PubMedID 22536922

  • Current Status of Pharmacologic Therapies in Patient Blood Management ANESTHESIA AND ANALGESIA Goodnough, L. T., Shander, A. 2013; 116 (1): 15-34


    Patient blood management(1,2) incorporates patient-centered, evidence-based medical and surgical approaches to improve patient outcomes by relying on the patient's own (autologous) blood rather than allogeneic blood. Particular attention is paid to preemptive measures such as anemia management. The emphasis on the approaches being "patient-centered" is to distinguish them from previous approaches in transfusion medicine, which have been "product-centered" and focused on blood risks, costs, and inventory concerns rather than on patient outcomes. Patient blood management(3) structures its goals by avoiding blood transfusion(4) with effective use of alternatives to allogeneic blood transfusion.(5) These alternatives include autologous blood procurement, preoperative autologous blood donation, acute normovolemic hemodilution, and intra/postoperative red blood cell (RBC) salvage and reinfusion. Reviewed here are the available pharmacologic tools for anemia and blood management: erythropoiesis-stimulating agents (ESAs), iron therapy, hemostatic agents, and potentially, artificial oxygen carriers.

    View details for DOI 10.1213/ANE.0b013e318273f4ae

    View details for Web of Science ID 000313145300004

    View details for PubMedID 23223098

  • How we treat: risk mitigation for ABO-incompatible plasma in plateletpheresis products TRANSFUSION Fontaine, M. J., Mills, A. M., Weiss, S., Hong, W., Viele, M., Goodnough, L. T. 2012; 52 (10): 2081-2085
  • Invited commentary. Annals of thoracic surgery Goodnough, L. T., Levy, J. H. 2012; 94 (3): 709-?

    View details for DOI 10.1016/j.athoracsur.2012.04.016

    View details for PubMedID 22916742

  • Mortality Benefit With Prasugrel in the TRITON-TIMI 38 Coronary Artery Bypass Grafting Cohort Risk-Adjusted Retrospective Data Analysis JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Smith, P. K., Goodnough, L. T., Levy, J. H., Poston, R. S., Short, M. A., Weerakkody, G. J., LeNarz, L. A. 2012; 60 (5): 388-396


    The objective of this study was to characterize the bleeding, transfusion, and other outcomes of patients related to the timing of prasugrel or clopidogrel withdrawal before coronary artery bypass grafting (CABG).There is little evidence to guide clinical decision making regarding the use of prasugrel in patients who may need urgent or emergency CABG. Experience with performing CABG in the presence of clopidogrel has raised concern about perioperative bleeding complications that are unresolved.A subset of the TRITON-TIMI 38 study (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis In Myocardial Infarction 38), in which patients with acute coronary syndrome were randomized to treatment with aspirin and either clopidogrel or prasugrel, underwent isolated CABG (N = 346). A supplemental case report form was designed and administered, and the data combined with the existing TRITON-TIMI 38 database. Baseline imbalances were corrected for using elements of the European System for Cardiac Operative Risk Evaluation and The Society of Thoracic Surgeons predictive algorithm.A significantly higher mean 12-h chest tube blood loss (655 ± 580 ml vs. 503 ± 378 ml; p = 0.050) was observed with prasugrel compared with clopidogrel, without significant differences in red blood cell transfusion (2.1 U vs. 1.7 U; p = 0.442) or the total donor exposure (4.4 U vs. 3.0 U; p = 0.463). All-cause mortality was significantly reduced with prasugrel (2.31%) compared with 8.67% with clopidogrel (adjusted odds ratio: 0.26; p = 0.025).Despite an increase in observed bleeding, platelet transfusion, and surgical re-exploration for bleeding, prasugrel was associated with a lower rate of death after CABG compared with clopidogrel.

    View details for DOI 10.1016/j.jacc.2012.03.030

    View details for Web of Science ID 000306694300006

    View details for PubMedID 22633653

  • Operational, Quality, and Risk Management in the Transfusion Service: Lessons Learned TRANSFUSION MEDICINE REVIEWS Goodnough, L. T. 2012; 26 (3): 252-261


    For general health care, the difference between quality and safety has been unclear for measurable patient outcomes. In contrast, in the transfusion service (TS), the relationship between quality and safety has been direct and demonstrable. Case studies are summarized to illustrate the relationship between operations, quality management, and risk management in the TS. In blood availability for elective surgery over 3 audited intervals, the incidence of patients undergoing elective surgery without available crossmatched blood that had been requested was 1:333, 1:328, and 1:225 for pre-quality improvement, post-quality improvement, and subsequent postintervention audit assessment, respectively. In event discovery reports (EDRs) over 2 years, incidence of biologic product deviation reports (Food and Drug Administration reportable) was successfully reduced from 60 biologic product deviation reports (12%) of 507 EDRs in 2009 to 42 (12%) of 336 EDRs in 2010. In wrong blood in tube, 102 specimens were identified (by a change in patient's ABO/Rh) from 176,711 type and screen/cross-match specimens received over a 5-year interval, detected either by previous patient record of ABO/Rh or by a second specimen for blood type confirmation implemented in our TS for the last 3 years. No known cases of "mismatched" red blood cell transfusion have occurred during this interval. There is an inverse relationship between resources/time expended on quality and risk management relative to volumes of operations in the TS. Laboratory-based initiatives that improve patient safety and clinical outcomes need to have resources aligned with the personnel and time required for quality management and risk management.

    View details for DOI 10.1016/j.tmrv.2011.10.002

    View details for Web of Science ID 000305661700005

    View details for PubMedID 22138578

  • Iron deficiency syndromes and iron-restricted erythropoiesis (CME) TRANSFUSION Goodnough, L. T. 2012; 52 (7): 1584-1592


    The relationships between erythropoietin (EPO), iron, and erythropoiesis and the presence of iron-restricted erythropoiesis have important implications in anemia management. Iron-restricted erythropoiesis occurs in the presence of one or more iron deficiency syndromes: absolute iron deficiency, functional iron deficiency, and/or iron sequestration. Absolute iron deficiency is a common nutritional deficiency in women's health, pediatrics, and the elderly and is therefore an important public health problem. Functional iron deficiency occurs in patients with significant EPO-mediated erythropoiesis or therapy with erythropoiesis-stimulating agents, even when storage iron is present. Iron sequestration mediated by hepcidin is an underappreciated but common cause of iron-restricted erythropoiesis in patients with chronic inflammatory disease. The challenge for treating and laboratory-based physicians is to understand the contributory role(s) of each of these syndromes, so that the potential value of emerging and innovative pharmacologic strategies can be considered as options in patient blood management.

    View details for DOI 10.1111/j.1537-2995.2011.03495.x

    View details for Web of Science ID 000306289500027

    View details for PubMedID 22211566

  • Postpartum hemorrhage treated with a massive transfusion protocol at a tertiary obstetric center: a retrospective study INTERNATIONAL JOURNAL OF OBSTETRIC ANESTHESIA Gutierrez, M. C., GOODNOUGH, L. T., Druzin, M., Butwick, A. J. 2012; 21 (3): 230-235


    A massive transfusion protocol may offer major advantages for management of postpartum hemorrhage. The etiology of postpartum hemorrhage, transfusion outcomes and laboratory indices in obstetric cases requiring the massive transfusion protocol were retrospectively evaluated in a tertiary obstetric center.We reviewed medical records of obstetric patients requiring the massive transfusion protocol over a 31-month period. Demographic, obstetric, transfusion, laboratory data and adverse maternal outcomes were abstracted.Massive transfusion protocol activation occurred in 31 patients (0.26% of deliveries): 19 patients (61%) had cesarean delivery, 10 patients (32%) had vaginal delivery, and 2 patients (7%) had dilation and evacuation. Twenty-six patients (84%) were transfused with blood products from the massive transfusion protocol. The protocol was activated within 2h of delivery for 17 patients (58%). Median [IQR] total estimated blood loss value was 2842 [800-8000]mL. Median [IQR] number of units of red blood cells, plasma and platelets from the massive transfusion protocol were: 3 [1.75-7], 3 [1.5-5.5], and 1 [0-2.5] units, respectively. Mean (SD) post-resuscitation hematologic indices were: hemoglobin 10.3 (2.4)g/dL, platelet count 126 (44)×10(9)/L, and fibrinogen 325 (125)mg/dL. The incidence of intensive care admission and peripartum hysterectomy was 61% and 19%, respectively.Our massive transfusion protocol provides early access to red blood cells, plasma and platelets for patients experiencing unanticipated or severe postpartum hemorrhage. Favorable hematologic indices were observed post resuscitation. Future outcomes-based studies are needed to compare massive transfusion protocol and non-protocol based transfusion strategies for the management of hemorrhage.

    View details for DOI 10.1016/j.ijoa.2012.03.005

    View details for Web of Science ID 000307685000005

    View details for PubMedID 22647592

  • A Reappraisal of Plasma, Prothrombin Complex Concentrates, and Recombinant Factor VIIa in Patient Blood Management CRITICAL CARE CLINICS Goodnough, L. T. 2012; 28 (3): 413-?


    Plasma therapy and plasma products such as prothrombin complex concentrates (PCCs), and recombinant activated factor VII (rFVIIa) are used in the setting of massive or refractory hemorrhage. Their roles have evolved because of newly emerging options, variable availability, and heterogeneity in guidelines. These factors can be attributable to lack of evidence-based support for a defined role for plasma therapy, variability in coagulation factor content among PCCs, and uncertainty regarding safety and efficacy of rFVIIa in these settings. This review summarizes these issues and provides insight regarding use of these options in management of refractory or massive bleeding.

    View details for DOI 10.1016/j.ccc.2012.04.002

    View details for Web of Science ID 000306871200008

    View details for PubMedID 22713615

  • Patient Blood Management ANESTHESIOLOGY Goodnough, L. T., Shander, A. 2012; 116 (6): 1367-1376

    View details for DOI 10.1097/ALN.0b013e318254d1a3

    View details for Web of Science ID 000304356500028

    View details for PubMedID 22487863

  • Use of point-of-care testing for plasma therapy TRANSFUSION Goodnough, L. T., Hill, C. C. 2012; 52: 56S-64S


    Use of point-of-care testing (POCT) has been driven by limitations of laboratory-based testing as a tool for decisions for transfusions of blood components. Clinical settings such as liver transplantation, cardiothoracic surgery, and trauma are particularly in need of such diagnostic tests because of the complex coagulopathies that can develop in these settings of substantial hemorrhage and need for blood component support. Successful implementation of POCT requires collaboration between surgery, anesthesia, critical care, and the laboratory to ensure proper quality control of equipment, operator training and competency, medical records test results, billing procedures, and consensus-derived transfusion algorithms for cost-effective, targeted blood component transfusion support. In this review we summarize clinical evidence for the effectiveness of POCT, along with some future directions for this strategy.

    View details for DOI 10.1111/j.1537-2995.2012.03624.x

    View details for Web of Science ID 000303920100009

    View details for PubMedID 22578372

  • A novel allocation strategy for blood transfusions: investigating the tradeoff between the age and availability of transfused blood TRANSFUSION Atkinson, M. P., Fontaine, M. J., Goodnough, L. T., Wein, L. M. 2012; 52 (1): 108-117


    Recent studies show that transfusing older blood may lead to increased mortality. This raises the issue of whether transfusing fresher blood can be achieved without jeopardizing blood availability.We propose a simple family of policies that is defined by a single threshold: rather than transfusing the oldest available blood that is younger than 42 days, we transfuse the oldest blood that is younger than the threshold, and if there is no blood younger than the threshold then we transfuse the youngest blood that is older than the threshold. To assess this policy, we build a simulation model using data from Stanford University Medical Center. We focus on the tradeoff between the mean age of transfused blood and the fraction of transfused blood that is imported.For hospitals in which the local supply is greater than demand, our policy with a threshold of 14 days leads to a decrease of 10 to 20 days in the mean age of transfused blood while increasing the fraction of imported blood to less than 0.005 (i.e., 0.5%). If the health benefits from transfusing fresher blood can be confirmed by randomized clinical trials, then conservative assumptions suggest that this policy could reduce the annual number of transfused patients who die within 1 year by 20,000.The proposed allocation policy with a threshold of 14 days could allow many US hospitals to significantly reduce the age of transfused blood, thereby possibly reducing morbidity and mortality, while having a negligible impact on supply chain operations.

    View details for DOI 10.1111/j.1537-2995.2011.03239.x

    View details for Web of Science ID 000298736000016

    View details for PubMedID 21756261

  • How we treat: transfusion medicine support of obstetric services TRANSFUSION Goodnough, L. T., Daniels, K., Wong, A. E., Viele, M., Fontaine, M. F., Butwick, A. J. 2011; 51 (12): 2540-2548


    Obstetric services depend on the transfusion service (TS) to provide diagnostic testing and blood component therapy for clinical care pathways.We describe three quality improvement (QI) initiatives implemented to improve TS support of obstetric services.We implemented a pathway for patients requiring an ABO/Rh order for every admission to obstetric services, along with reconciliation of the daily hospital birth manifest and TS umbilical cord log to identify every woman eligible for RhIG. After assessment over 6 months, 21 (1%) of 2041 women lacked an admission ABO/Rh; all subsequently had ABO/Rh determinations. Umbilical cords were missing for eight (0.4%) mothers; four were D- and received RhIG. We developed algorithms for diagnostic blood ordering for patients deemed at "low,"moderate," or "high" risk of blood transfusion. A 27% reduction in total diagnostic test volumes and 24% reduction in charges was documented after compared to before implementation. We analyzed the impact of our massive transfusion protocol (MTP) on blood inventory management for 31 (0.25%) women undergoing 12,945 deliveries, representing 11% of 286 MTPs for all clinical services over a 32-month interval. O- uncrossmatched red blood cells (RBCs) represented 103 (24%) of 421 RBC units issued. Wastage rates of RBCs, plasma, and platelets ordered and issued in the MTPs were 0.7, 16, and 3%, respectively.QI initiatives for RhIG prophylaxis, diagnostic blood test ordering, and MTP improve TS support of obstetric services.

    View details for DOI 10.1111/j.1537-2995.2011.03152.x

    View details for Web of Science ID 000298340300006

    View details for PubMedID 21542850

  • Complement (C1q) fixing solid-phase screening for HLA antibodies increases the availability of compatible platelet components for refractory patients TRANSFUSION Fontaine, M. J., Kuo, J., Chen, G., Galel, S. A., Miller, E., Sequeira, F., Viele, M., Goodnough, L. T., Tyan, D. B. 2011; 51 (12): 2611-2618


    Immune refractoriness to platelet (PLT) transfusion is primarily due to HLA antibody. Patients at our institution are identified as refractory due to HLA by a Luminex-based immunoglobulin (Ig)G-single-antigen-bead (SAB) assay, but in highly sensitized patients, antigen-negative compatible donors cannot be found due to the high sensitivity of the IgG-SAB method. We developed an assay that detects only HLA antibodies binding the first complement component (C1q). We hypothesized that the C1q-SAB method might be more relevant than the IgG-SAB method because the antibodies identified may activate the complement cascade causing PLT destruction.Thirteen highly sensitized refractory patients received 177 PLT units incompatible by the IgG-SAB method. They were retrospectively retested by the C1q-SAB method. Calculated percent reactive antibody (CPRA) and HLA antibody specificities were compared between the two methods and corrected count increment (CCI) values were analyzed. Additionally the impact of ABO compatibility on CCI responses was evaluated.The mean CPRA value was significantly lower by C1q-SAB (60%) than by IgG-SAB (94%; p < 0.05). Patients showed significantly better CCI (10.6 × 10(9) ± 0.8 × 10(9) /L) with C1q-compatible (n = 134) than with C1q-incompatible PLTs (n = 43) (2.5 × 10(9) ± 0.9 × 10(9) /L/m(2) ; p < 0.0001). ABO compatibility did not significantly impact the CCI values (p < 0.0001). Our results show that 75% of PLT units previously considered incompatible were actually compatible.For highly refractory patients to PLT transfusion, the C1q-based SAB binding assay may be a better method for identifying clinically relevant HLA antibodies and selecting PLT units that will result in acceptable CCI.

    View details for DOI 10.1111/j.1537-2995.2011.03194.x

    View details for Web of Science ID 000298340300015

    View details for PubMedID 21615749

  • Massive Transfusion Protocols for Patients With Substantial Hemorrhage TRANSFUSION MEDICINE REVIEWS Young, P. P., Cotton, B. A., Goodnough, L. T. 2011; 25 (4): 293-303


    Transfusion medicine for the resuscitation of patients with massive hemorrhage has recently advanced from reactive, supportive treatment with crystalloid and red blood cell therapy to use of standardized massive transfusion protocols (MTPs). Through MTPs, medical facilities are able to standardize the most effective posthemorrhage treatments and execute them rapidly while reducing potential waste of blood products. Damage control resuscitation is an example of an MTP, where patients are (1) allowed more permissive hypotension, (2) spared large volumes of crystalloid/colloid therapy (through low volume resuscitation), and (3) transfused with blood products preemptively using a balanced ratio of plasma and platelets to red blood cells. This focused approach improves the timely availability of blood components during resuscitation. However, the use of MTPs remains controversial. This review describes published experiences with MTPs and illustrates the potential value of several MTPs currently utilized by academic transfusion services.

    View details for DOI 10.1016/j.tmrv.2011.04.002

    View details for Web of Science ID 000295186700002

    View details for PubMedID 21664104

  • How I treat warfarin-associated coagulopathy in patients with intracerebral hemorrhage BLOOD Goodnough, L. T., Shander, A. 2011; 117 (23): 6091-6099


    Intracerebral hemorrhage in patients with warfarin-associated coagulopathy is an increasingly common life-threatening condition that requires emergent management. The evolution of therapeutic options in this setting, as well as recently published guidelines, has resulted in some heterogeneity in recommendations by professional societies. This heterogeneity can be attributed to lack of evidence-based support for plasma therapy; the variability in availability of prothrombin complex concentrates; the variability in the coagulation factor levels and contents of prothrombin complex concentrates; ambiguity about the optimal dose and route of administration of vitamin K; and the lack of standardized clinical care pathways, particularly in community hospitals, for the management of these critical care patients. In this review, we summarize the relevant literature about these controversies and present recommendations for management of patients with warfarin-associated coagulopathy and intracerebral hemorrhage.

    View details for DOI 10.1182/blood-2010-11-316075

    View details for Web of Science ID 000291438000009

    View details for PubMedID 21411756

  • Quality management in the transfusion service: case studies in process improvement TRANSFUSION Goodnough, L. T., Viele, M., Fontaine, M., Chua, L., Ferrer, Z., Jurado, C., Quach, P., Dunlap, M., Arber, D. A. 2011; 51 (3): 600-609


    Laboratory-based quality improvement (QI) initiatives can improve clinical outcomes and patient safety.We present three cases of QI that impact processes from the transfusion service (TS) laboratory to the patient's bedside.Case 1 was event discovery reporting (EDR). We were able to reduce our biologic product deviation reports from 41 (17%) of 238 EDRs to only 19 (7%) of 272 (p < 0.01) EDRs after implementation of a QI workflow process. Case 2 was antibody evaluation before elective surgery. We implemented process improvement strategies: 1) surgical safety checklist with confirmation of type-and-screen completion and antibody evaluation before patients can proceed to surgery; 2) specimen retention policy of 30 days to allow advance testing; and 3) daily review to identify specimens needed on day of surgery. After intervention, only 7 (0.3%) of 2298 patients required antibody evaluation on day of surgery, compared to 65 (0.75%) of 8656 patients (p < 0.01) before intervention. Case 3 was wrong blood in tube (WBIT). We have a two-specimen requirement for blood type verification before transfusion. To determine whether trauma patients should be exempted, we reviewed WBIT errors. Six WBIT errors were from the emergency department (an error rate of 1:400) and nine WBIT specimens were institution-wide. Three patients were transfused after correction of the WBIT error. Based on this analysis, our institution agreed that no clinical units shall be exempted from our policy.Successful QI in the TS improves processes that promote efficiency, effectiveness, and patient safety.

    View details for DOI 10.1111/j.1537-2995.2010.02857.x

    View details for Web of Science ID 000288166200023

    View details for PubMedID 20738826

  • Detection, evaluation, and management of preoperative anaemia in the elective orthopaedic surgical patient: NATA guidelines BRITISH JOURNAL OF ANAESTHESIA Goodnough, L. T., Maniatis, A., Earnshaw, P., Benoni, G., Beris, P., Bisbe, E., Fergusson, D. A., Gombotz, H., Habler, O., Monk, T. G., Ozier, Y., Slappendel, R., Szpalski, M. 2011; 106 (1): 13-22


    Previously undiagnosed anaemia is common in elective orthopaedic surgical patients and is associated with increased likelihood of blood transfusion and increased perioperative morbidity and mortality. A standardized approach for the detection, evaluation, and management of anaemia in this setting has been identified as an unmet medical need. A multidisciplinary panel of physicians was convened by the Network for Advancement of Transfusion Alternatives (NATA) with the aim of developing practice guidelines for the detection, evaluation, and management of preoperative anaemia in elective orthopaedic surgery. A systematic literature review and critical evaluation of the evidence was performed, and recommendations were formulated according to the method proposed by the Grades of Recommendation Assessment, Development and Evaluation (GRADE) Working Group. We recommend that elective orthopaedic surgical patients have a haemoglobin (Hb) level determination 28 days before the scheduled surgical procedure if possible (Grade 1C). We suggest that the patient's target Hb before elective surgery be within the normal range, according to the World Health Organization criteria (Grade 2C). We recommend further laboratory testing to evaluate anaemia for nutritional deficiencies, chronic renal insufficiency, and/or chronic inflammatory disease (Grade 1C). We recommend that nutritional deficiencies be treated (Grade 1C). We suggest that erythropoiesis-stimulating agents be used for anaemic patients in whom nutritional deficiencies have been ruled out, corrected, or both (Grade 2A). Anaemia should be viewed as a serious and treatable medical condition, rather than simply an abnormal laboratory value. Implementation of anaemia management in the elective orthopaedic surgery setting will improve patient outcomes.

    View details for DOI 10.1093/bja/aeq361

    View details for Web of Science ID 000285192900004

    View details for PubMedID 21148637

  • Detection, evaluation, and management of iron-restricted erythropoiesis BLOOD Goodnough, L. T., Nemeth, E., Ganz, T. 2010; 116 (23): 4754-4761


    Progress in our understanding of iron-restricted erythropoiesis has been made possible by important advances in defining the molecular mechanisms of iron homeostasis. The detection and diagnostic classification of iron-restricted erythropoiesis can be a challenging process for the clinician. Newer assays for markers of inflammation may allow more targeted management of the anemia in these conditions. The availability of new intravenous iron preparations provides new options for the treatment of iron-restricted erythropoiesis. This review summarizes recent advances regarding the detection, evaluation, and management of iron-restricted erythropoiesis.

    View details for DOI 10.1182/blood-2010-05-286260

    View details for Web of Science ID 000284880200011

    View details for PubMedID 20826717

  • Erythropoiesis stimulating agents, blood transfusion, and the practice of medicine AMERICAN JOURNAL OF HEMATOLOGY Goodnough, L. T., Shander, A. S. 2010; 85 (11): 835-837

    View details for DOI 10.1002/ajh.21870

    View details for Web of Science ID 000283568200001

    View details for PubMedID 20890909

  • Impact of cytomegalovirus (CMV) antibody reflex testing in the transfusion service on management of CMV-seronegative blood inventory TRANSFUSION Fontaine, M. J., Jurado, C., Miller, E., Viele, M., Goodnough, L. T. 2010; 50 (8): 1685-1689


    Our goal is to minimize unnecessary cytomegalovirus (CMV)-seronegative blood transfusion to preserve the CMV-seronegative blood inventory for patients who are identified as CMV seronegative.We implemented a CMV antibody reflex testing protocol for patients who require CMV-compatible blood but in whom a CMV serostatus is unknown (coded as CMVT in our computer system). A solid-phase red blood cell (RBC) adherence antibody detection system was validated to detect CMV antibodies in plasma samples (received for ABO/Rh type and RBC antibody screen) with acceptable sensitivity and specificity. We evaluated the impact of this CMV antibody reflex testing on the management of RBC and platelet (PLT) inventory for patients requiring CMV-compatible blood.Over a 16-month period, implementation of CMV antibody reflex testing identified 361 (34%) of 1063 previously CMV-untested patients who required CMV-compatible blood and who were CMV seronegative. We observed a 75% decrease in the number of CMVT patients in our data base from 190 per month before implementation to 57 at 16 months postimplementation. Consequently we reevaluated the percentage in our blood inventory of CMV-seronegative units required while potentially saving 1234 CMV-seronegative blood products (835 RBCs and 399 PLTs) each month.A strategy of performing CMV antibody reflex testing in the transfusion service allows more effective blood inventory management and control in maintaining a CMV-seronegative blood inventory dedicated for patients who truly require it.

    View details for DOI 10.1111/j.1537-2995.2010.02643.x

    View details for Web of Science ID 000280596700010

    View details for PubMedID 20412530

  • Recombinant factor VIIa: an assessment of evidence regarding its efficacy and safety in the off-label setting. Hematology / the Education Program of the American Society of Hematology. American Society of Hematology. Education Program Logan, A. C., Goodnough, L. T. 2010; 2010: 153-159


    Recombinant human factor VIIa (rFVIIa) is approved by the US Food and Drug Administration for use in the setting of hemorrhage associated with factor VIII or factor IX inhibitors in patients with congenital or acquired hemophilia. This indication represents only a small number of bleeding conditions. Since it became available, rFVIIa has been increasingly used in the management of off-label indications, ranging from emergent hemostasis in traumatic hemorrhage to prophylactic hemostasis in patients undergoing major surgery. Prominent off-label indications include the management of patients with coagulopathies, such as occurs in trauma patients experiencing massive and uncontrolled hemorrhage, and in patients undergoing cardiovascular surgery with cardiopulmonary bypass. Other occasions for use occur in patients with intact coagulation systems, with nontraumatic intracranial hemorrhage being the most common in this group. Uncertainties regarding the efficacy and safety associated with use of rFVIIa in these off-label scenarios have led to evidence-based assessments of patient outcomes, including mortality, the rate of thromboembolic adverse events, and posttreatment functional status. We review the evidence regarding the efficacy and safety of this important, but controversial, hemostatic agent in the off-label setting.

    View details for DOI 10.1182/asheducation-2010.1.153

    View details for PubMedID 21239786

  • Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial TRANSFUSION Van Wyck, D. B., Mangione, A., Morrison, J., Hadley, P. E., Jehle, J. A., Goodnough, L. T. 2009; 49 (12): 2719-2728


    The objective was to evaluate efficacy and safety of rapid, large-dose intravenous (IV) administration of ferric carboxymaltose compared to oral iron in correcting iron deficiency anemia due to heavy uterine bleeding.In a randomized, controlled trial, 477 women with anemia, iron deficiency, and heavy uterine bleeding were assigned to receive either IV ferric carboxymaltose (or= 12 g/dL) of anemia (73% vs. 50%, p < 0.001). Patients treated with ferric carboxymaltose compared to those prescribed ferrous sulfate reported greater gains in vitality and physical function and experienced greater improvement in symptoms of fatigue (p < 0.05). There were no serious adverse drug events.In patients with iron deficiency anemia due to heavy uterine bleeding, rapid IV administration of large doses of a new iron agent, ferric carboxymaltose, is more effective than oral iron therapy in correcting anemia, replenishing iron stores, and improving quality of life.

    View details for DOI 10.1111/j.1537-2995.2009.02327.x

    View details for Web of Science ID 000272344900024

    View details for PubMedID 19682342

  • The New Age of Iron: Evaluation and Management of Iron-Restricted Erythropoiesis SEMINARS IN HEMATOLOGY Goodnough, L. T. 2009; 46 (4): 325-327

    View details for Web of Science ID 000270562700001

    View details for PubMedID 19786200

  • Retrospective analysis of transfusion outcomes in pregnant patients at a tertiary obstetric center INTERNATIONAL JOURNAL OF OBSTETRIC ANESTHESIA Butwick, A. J., Aleshi, P., Fontaine, M., Riley, E. T., GOODNOUGH, L. T. 2009; 18 (4): 302-308


    The decision to use red blood cell transfusion and/or blood products (fresh frozen plasma, platelets, cryoprecipitate) to manage obstetric hemorrhage or treat postpartum anemia is often made empirically by physicians. We performed a retrospective study to review transfusion outcomes in pregnant and postpartum patients at a large obstetric center.A retrospective, observational study was performed of obstetric in-patients who received red blood cell transfusion and/or blood products over a one-year period. Data abstracted included transfusion data, pre-transfusion hemoglobin (Hb) and lowest recorded (nadir) Hb, and maternal and neonatal outcomes.During the study period, 74 patients received transfusion therapy (1.4%). Pre-transfusion and nadir Hb values were 7.6 g/dL and 7.0 g/dL respectively. Median [IQR] total red blood cells transfused were 2 units [2-3], with 41 (55%) patients receiving 1-2 units. Based on chart review, no specific indications for transfusion were identified in 25 patients (34%), and 13 patients (18%) had undetected postpartum anemia (Hb values <8.2 g/dL) at least 24h after delivery.More formal assessment and documentation of the etiologic factors associated with transfusion management in pregnant patients is advised. In addition, the identification and management of undetected postpartum anemia is underappreciated.

    View details for DOI 10.1016/j.ijoa.2009.02.005

    View details for Web of Science ID 000271135300002

    View details for PubMedID 19628384

  • Improving platelet supply chains through collaborations between blood centers and transfusion services TRANSFUSION Fontaine, M. J., Chung, Y. T., Rogers, W. M., Sussmann, H. D., Quach, P., Galel, S. A., Goodnough, L. T., Erhun, F. 2009; 49 (10): 2040-2047


    Blood centers and hospital transfusion services are challenged with maintaining an adequate platelet (PLT) inventory to minimize the number of outdated units without risking a major shortage. A novel approach to inventory management was established at our institution through a collaboration between the Stanford University Medical Center (SUMC) Transfusion Service, the Stanford Blood Center (SBC), and the Department of Management Science and Engineering.An analysis of the supply chain performance between SBC and SUMC Transfusion Service was performed. First, the interaction between processes, such as blood collection, rotation, and inventory management, was studied. Second, changes were implemented based on the recommendations from the analysis team. Finally, a postanalysis was performed reflecting on the improvement of the operations between SUMC and SBC.A comprehensive data analysis of the PLT supply chain allowed the identification of three series of improvements to be implemented: 1) on SBC's PLT collection, 2) on SBC's rotation process, and 3) on the PLT inventory management policy at SUMC. A postimplementation analysis showed a reduction in the overall PLT outdate rate from 19% in the first quarter of 2006, down to 9% in the third quarter of 2008.A multidisciplinary effort among SUMC Transfusion Service, SBC, and experts in supply chain management resulted in a process improvement, which reduced the rate of PLT outdate at both SBC and SUMC Transfusion Service down to 9%, with a significant cost reduction of more than half a million dollars per year.

    View details for DOI 10.1111/j.1537-2995.2009.02236.x

    View details for Web of Science ID 000270430100008

    View details for PubMedID 19538430

  • Implementation of a two-specimen requirement for verification of ABO/Rh for blood transfusion TRANSFUSION Goodnough, L. T., Viele, M., Fontaine, M. J., Jurado, C., Stone, N., Quach, P., Chua, L., Chin, M., Scott, R., Tokareva, I., Tabb, K., Sharek, P. J. 2009; 49 (7): 1321-1328


    This study presents our implementation of a two-specimen requirement with no prior record of ABO/Rh to verify patients' blood type before transfusion.Blood type verification was introduced, discussed, approved, and implemented over a 12-month period (May 2007 to May 2008). Potential barriers and impact on benchmark indicators were identified and tracked.Inpatient identification and/or specimen labeling for nursing and laboratory phlebotomists baseline corrected error rates were 1:467 and 1:5555, respectively. This study therefore sought and obtained approval to initiate a new policy of blood type verification before blood transfusion. Compliance in turnaround time (TAT) before and after implementation for completion of STAT type and screen/crossmatch within 60 minutes worsened marginally, from 90% to 80%. The impact on use of O-, uncrossmatched blood was found to be manageable. Seven (of 25 total) recorded electronic complaints were received after implementation. The corrected error rate for nurse phlebotomy draws after implementation was 1:630.Despite the lack of an instigating event, verification of blood type before blood transfusion was successfully implemented. An impact on resources and benchmark indicators such as TAT can be anticipated and managed. Further process improvement efforts will be needed to ensure safety (e.g., at time of blood transfusion) for patients receiving blood transfusions. ABO/Rh verification may be necessary even after future implementation of bar coding and/or RFID chips, because human errors continue to occur even with systems improvements.

    View details for DOI 10.1111/j.1537-2995.2009.02157.x

    View details for Web of Science ID 000267715300010

    View details for PubMedID 19389026

  • A case of no pain and no gain from blood? CRITICAL CARE MEDICINE Shander, A., Goodnough, L. T. 2009; 37 (6): 2104-2105

    View details for DOI 10.1097/CCM.0b013e3181a5e3c3

    View details for Web of Science ID 000266300300043

    View details for PubMedID 19448456

  • Why an Alternative to Blood Transfusion? CRITICAL CARE CLINICS Shander, A., Goodnough, L. T. 2009; 25 (2): 261-?


    Allogeneic blood transfusions have been associated with several risks and complications and with worse outcomes in a substantial number of patient populations and clinical scenarios. Allogeneic blood is costly and difficult to procure, transport, and store. Global and local shortages are imminent. Alternatives to transfusion provide many advantages, and their use is likely to improve outcomes as safer and more effective agents are developed.

    View details for DOI 10.1016/j.ccc.2008.12.012

    View details for Web of Science ID 000265560000002

    View details for PubMedID 19341908

  • Iron overload and toxicity: the hidden risk of multiple blood transfusions VOX SANGUINIS Shander, A., Cappellini, M. D., GOODNOUGH, L. T. 2009; 97 (3): 185-197


    The quantity of iron in body is carefully regulated, primarily by control of iron absorption, and excess total body iron can be extremely toxic. Since humans have no mechanism for elimination of excess iron, multiple transfusions of red blood cells, which are required for the management of a number of disorders, inevitably result in iron overload. Cumulative iron overload, in turn, leads to iron toxicity with organ dysfunction and damage.This review examines the relationship between iron metabolism and hematologic disorders treated with multiple transfusions, with emphasis on the diagnosis and current methods of management of iron overload and toxicity in transfusion-dependent patients. Primarily using key words, we identified and reviewed more than 100 pertinent articles in English and other languages in the Medline database plus an additional number of abstracts of presentations at recent meetings of relevant scientific associations.Transfusion-dependent disorders include those characterized by decreased red blood cell production, increased red blood cell destruction, or chronic blood loss. Patients receiving chronic transfusion therapy should be screened and monitored for iron overload, yet in our opinion, this is not always done routinely. Once iron overload has been identified, it should be treated to reduce the risk of morbidity and mortality from iron toxicity, which particularly affects the liver and heart.Increased awareness of the risks of iron overload from chronic transfusion therapy should result in greater use of interventions such as iron chelation to reduce total body iron and the risk of long-term sequelae.

    View details for DOI 10.1111/j.1423-0410.2009.01207.x

    View details for Web of Science ID 000270182800001

    View details for PubMedID 19663936

  • The role of intravenous iron in anemia management and transfusion avoidance TRANSFUSION Auerbach, M., Goodnough, L. T., Picard, D., Maniatis, A. 2008; 48 (5): 988-1000
  • Impact of clinical trial design and execution-related factors on incidence of thromboembolic events in cancer patients: a systematic review and metaanalysis CURRENT MEDICAL RESEARCH AND OPINION Reynolds, M. W., Shibata, A., Zhao, S., Jones, N., Fahrbach, K., Goodnough, L. T. 2008; 24 (2): 497-505


    The objective of this study was to quantify the incidence of thromboembolic events (specifically, deep vein thromboses [DVT] and pulmonary embolism [PE]) in patients with cancer, and to examine the effects of a major clinical trial design and execution factors on those incidence rates.The study included a systematic review of Medline, Current Contents, and accepted study bibliographies, as well as an analysis of studies. Studies included both longitudinal studies (prospective and retrospective) published in the English language between January 1990 and October 2005. Studies of patients with cancer that reported the incidence of thromboembolic events (DVT, PE, and total venous thromboembolic events [VTE]) were eligible for inclusion. Incidence of these events was calculated by study design, surveillance type (active or passive), length of follow-up, and other treatment risk factors. Incidence rates were estimated by random effects Poisson meta-regression modeling.One hundred and eighty-three studies met all inclusion criteria. Incidence rates of all outcomes (DVT, PE, and total VTE) were 3-55 times higher for active surveillance than for passive surveillance. Studies with a follow-up time 6 months. Additionally, the incidence rates for all outcome events when using passive surveillance were 3-12 times higher in non-randomized clinical trials (non-RCTs) than in RCTs.These results provide a benchmark for the incidence of thromboembolic events in patients with cancer. Factors such as study design, length of follow-up, and method of case ascertainment (type of surveillance - active or passive) must be considered when interpreting thromboembolic incidence rates. This review is comprehensive in its inclusion of all studies with a scientific objective of examining the risk of thromboembolic events in patients with cancer from 1990 to 2005. However, other studies published prior to 1990, more recently than 2005, or with other scientific objectives in their research may also provide supportive information to these risk estimates.

    View details for DOI 10.1185/0300799O8X261050

    View details for Web of Science ID 000253902900020

    View details for PubMedID 18194590

  • Do preoperative anemia and polycythemia affect clinical outcome in patients undergoing major surgery? NATURE CLINICAL PRACTICE CARDIOVASCULAR MEDICINE Shander, A., Goodnough, L. T. 2008; 5 (1): 20-21

    View details for DOI 10.1038/ncpcardio1033

    View details for Web of Science ID 000251696200008

    View details for PubMedID 17940515

  • Alloimmunization to red blood cell antigens affects clinical outcomes in liver transplant patients LIVER TRANSPLANTATION Boyd, S. D., Stenard, F., Lee, D. K., Goodnough, L. T., Esquivel, C. O., Fontaine, M. J. 2007; 13 (12): 1654-1661


    Transfusion therapy of liver transplant patients remains a challenge. High volumes of intraoperative blood transfusion have been shown to increase the risk of poor graft or patient survival. We conducted a retrospective study of 209 consecutive liver transplant cases at our institution. Only patients receiving their first liver transplant, with no other simultaneous organ transplants, were included. Cox proportional hazard modeling was used to identify clinical variables correlated with postoperative patient mortality. Statistically significant variables for poor patient survival were the number of red blood cell and plasma units transfused, a history of red blood cell alloantibodies, and the immunosuppressive regimen used. History of pregnancy also approached statistical significance but was less robust than the other 3 variables. Our findings suggest that blood transfusion and immune modulation greatly affect the survival of patients after liver transplantation.

    View details for DOI 10.1002/It.21241

    View details for Web of Science ID 000251574100007

    View details for PubMedID 18044783

  • A randomized double-blind trial of hydroxychloroquine for the prevention of chronic graft-versus-host disease after allogeneic peripheral blood stem cell transplantation BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION Fong, T., Trinkaus, A., Adkins, D., Vij, R., Devine, S. M., Tomasson, M., Goodnough, L. T., Lopez, S., Graubert, T., Shenoy, S., DiPersio, J. F., Khoury, H. Y. 2007; 13 (10): 1201-1206


    Hydroxychloroquine (HCQ) is an immunosuppressive lysosomotropic amine that has activity against graft-versus-host disease (GVHD). In a single-institution phase III trial, 95 recipients of allogeneic peripheral blood stem cell (PBSC) transplantation were randomized to receive, in a double-blind fashion, and in addition to prophylactic cyclosporine A (CSA), HCQ, or placebo starting 21 days pretransplant and continued until day +365. HCQ was very well tolerated and not associated with side effects. Overall, the incidence of acute GVHD (aGVHD) was 59% in both arms, and severe aGVHD occurred in 11% (HCQ) and 14% (placebo) (P = .76). Sixty percent and 78% of patients developed chronic GVHD (cGVHD) in the HCQ and the placebo arms, respectively (P = .15). With a median follow-up of 18 months, relapse-free and overall survivals (OS) were comparable in both groups. In summary, in this randomized trial, the addition of HCQ to single-agent CSA had no effects on aGVHD or cGVHD or survival.

    View details for DOI 10.1016/j.bbmt.2007.06.012

    View details for Web of Science ID 000250103400010

    View details for PubMedID 17889357

  • Transfusion triggers SURGERY Goodnough, L. T. 2007; 142 (4): S67-S70


    The decision to transfuse a patient is not always clear and straightforward, particularly because no single number, neither extraction ratio nor hemoglobin level, can serve as an absolute indicator of transfusion need. Clinical assessment of the patient in conjunction with physiologic values helps in determining the appropriateness of transfusion before the advent of hypoxia or ischemia. The benefit of transfusion in relation to mortality and morbidity is discussed here based on an assessment of the literature, and transfusion guidelines from several organizations are summarized.

    View details for DOI 10.1016/j.surg.2007.06.027

    View details for Web of Science ID 000250866500012

    View details for PubMedID 18019935

  • Recombinant factor VIIa: safety and efficacy CURRENT OPINION IN HEMATOLOGY Goodnougha, L. T., Shander, A. S. 2007; 14 (5): 504-509


    Recombinant factor VIIa has been increasingly used to provide hemostasis in nonapproved indications. This trend has resulted in concerns about safety, efficacy and costs.Recombinant factor VIIa seems to have hemostatic effects in posttrauma and perisurgery excessive bleeding, although further studies are required. Recombinant factor VIIa may be used to reverse the effect of warfarin or other vitamin K-antagonist therapy following vitamin K administration. Some beneficial effects have also been suggested in a limited number of patients with liver disease and hemorrhagic stroke. Recombinant factor VIIa should be used with caution in cases with known hypercoagulability, excessive bleeding in the setting of disseminated intravascular coagulation or other states of generalized activation of the hemostatic system. In most of the nonapproved cases, a 4.8-mg vial administered to an adult patient weighing 50-100 kg to achieve a 50-100 microg/kg dose is recommended.While consensus recommendations on the use of recombinant factor VIIa in nonapproved settings have been developed, more studies are needed to define dose and timing in these diverse patient populations. For now, decisions about off-label use of recombinant factor VIIa remain at the physician's discretion, assisted by hospital pharmacotherapeutic or transfusion committees.

    View details for Web of Science ID 000248781300013

    View details for PubMedID 17934358

  • Update on transfusion medicine PHARMACOTHERAPY Shander, A., Goodnough, L. T. 2007; 27 (9): 57S-68S


    Clinical pharmacists often participate on critical care teams that manage patients with bleeding emergencies. Although blood products are usually dispensed from the blood bank and not the pharmacy, pharmacists should be conversant in the language and trends of transfusion medicine, much like they are with other therapeutic agents. Toward that goal, this review provides a concise transfusion medicine tutorial, covering all commonly used blood products, including red blood cells, platelets, fresh frozen plasma, and plasma derivatives such as cryoprecipitate, prothrombin complex concentrates, and albumin. Usage patterns, the rationale for administering the various blood products, and studies that have attempted to determine appropriate criteria for ordering transfusions (transfusion triggers) are discussed. The benefits, risks, and several ongoing controversies that relate to the appropriateness and safety of blood product use are also summarized.

    View details for Web of Science ID 000249108800003

    View details for PubMedID 17723109

  • How we treat: management of life-threatening primary postpartum hemorrhage with a standardized massive transfusion protocol TRANSFUSION Burtelow, M., Riley, E., Druzin, M., Fontaine, M., Viele, M., Goodnough, L. T. 2007; 47 (9): 1564-1572


    Management of massive, life-threatening primary postpartum hemorrhage in the labor and delivery service is a challenge for the clinical team and hospital transfusion service. Because severe postpartum obstetrical hemorrhage is uncommon, its occurrence can result in emergent but variable and nonstandard requests for blood products. The implementation of a standardized massive transfusion protocol for the labor and delivery department at our institution after a maternal death caused by amniotic fluid embolism is described. This guideline was modeled on a existing protocol used by the trauma service mandating emergency release of 6 units of group O D- red cells (RBCs), 4 units of fresh frozen or liquid plasma, and 1 apheresis unit of platelets (PLTs). The 6:4:1 fixed ratio of uncrossmatched RBCs, plasma, and PLTs allows the transfusion service to quickly provide blood products during the acute phase of resuscitation and allows the clinical team to anticipate and prevent dilutional coagulopathy. The successful management of three cases of massive primary postpartum hemorrhage after the implementation of our new massive transfusion protocol in the maternal and fetal medicine service is described.

    View details for DOI 10.1111/j.1537-2995.2007.01404.x

    View details for Web of Science ID 000249330500002

    View details for PubMedID 17725718

  • Blood management ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE Goodnough, L. T., Shander, A. 2007; 131 (5): 695-701


    We provide an overview of the principles of blood management: the appropriate use of blood and blood components, with a goal of minimizing their use.To review the strategies that exploit combinations of surgical and medical techniques, technologic devices, and pharmaceuticals, along with an interdisciplinary team approach that combines specialists who are expert at minimizing allogeneic blood transfusion.A search on Medline and PubMed for the terms English and humans used in articles published within the last 20 years.Blood management is most successful when multidisciplinary, proactive programs are in place so that these strategies can be individualized to specific patients.

    View details for Web of Science ID 000246263100007

    View details for PubMedID 17488154

  • Erythropoietin and iron-restricted erythropoiesis EXPERIMENTAL HEMATOLOGY Goodnough, L. T. 2007; 35 (4): 167-172


    Twenty five years ago, Finch summarized knowledge gained primarily from studies of normal individuals, patients with hereditary hemolytic anemias, and patients with hemochromatosis [1]. Under conditions of basal erythropoiesis in normal subjects, plasma iron turnover (as an index of marrow erythropoietic response) is little affected, whether transferrin saturation ranges from very low to very high levels. In contrast, the erythropoietic response in individuals with congenital hemolytic anemia, in whom erythropoiesis is chronically raised up to sixfold over basal levels [2], is affected (and limited) by serum iron levels and by transferrin saturation [3]. Patients with hemochromatosis who underwent serial phlebotomy were observed to mount erythropoietic responses of up to eightfold over basal rates, attributed to the maintenance of very high serum iron and transferrin saturation levels in these patients [4], whereas normal individuals were shown to have difficulty providing sufficient iron to support rates of erythropoiesis greater than three times basal rates [5]. These observations led Finch to identify a "relative iron deficiency" state, also known as "functional iron deficiency," which he defined as circumstances in which increased erythron iron requirements exceed the available supply of iron [6]. In another clinical setting, patients undergoing autologous blood donation represent a model for perisurgical blood loss and the erythropoietic response. Insights gained over the last 20 years regarding the relationship between erythropoietin, iron, and erythropoiesis, along with implications for clinical management, will be reviewed.

    View details for DOI 10.1016/j.exphem.2007.01.026

    View details for Web of Science ID 000245577700025

    View details for PubMedID 17379103

  • Objectives and limitations of bloodless medical care CURRENT OPINION IN HEMATOLOGY Shander, A., Goodnough, L. T. 2006; 13 (6): 462-470


    To outline the rationale, limitations, and execution of bloodless medical and surgical programs, highlighting characteristics that contribute to successful outcomes.Clinical experiences with patients who refuse blood transfusions for religious reasons have provided valuable lessons and raise intriguing questions about the necessity of routine blood transfusions. Healthcare centers with bloodless medicine and surgery programs feature a novel concept of patient care aimed at improving outcomes. A one-tiered approach to minimize blood usage for all patients, regardless of religious beliefs, is being successfully adopted at an increasing number of institutions. Since most single blood-conservation techniques reduce blood usage by just 1-2 units, a series of integrated preoperative, intraoperative, and postoperative conservation approaches is required. These include preoperative autologous donation, erythropoietic support, acute normovolemic hemodilution, individualized assessment of anemia tolerance, implementation of conservative transfusion thresholds, meticulous surgical techniques, and judicious use of phlebotomy and pharmacologic agents for limiting blood loss.The objectives of bloodless medicine and surgery programs are straightforward but require staff with expertise in transfusion medicine, intensive teamwork, patient-specific customization, careful planning, and integrated use of multimodal strategies.

    View details for Web of Science ID 000241690600010

    View details for PubMedID 17053460

  • A randomized, controlled Phase III trial of therapeutic plasma exchange with fresh-frozen plasma (FFP) prepared with amotosalen and ultraviolet A light compared to untreated FFP in thrombotic thrombocytopenic purpura TRANSFUSION Mintz, P. D., Neff, A., MacKenzie, M., Goodnough, L. T., Hillyer, C., Kessler, C., McCrae, K., Menitove, J. E., Skikne, B. S., Damon, L., Lopez-Plaza, I., Rouault, C., Crookston, K. P., Benjamin, R. J., George, J., Lin, J., Corash, L., Conlan, M. G. 2006; 46 (10): 1693-1704


    Photochemical treatment of fresh-frozen plasma (FFP) with amotosalen and ultraviolet (UV) A light (PCT FFP) results in inactivation of a broad spectrum of pathogens while retaining coagulation factor activity, antithrombotic proteins, and von Willebrand factor-cleaving protease (VWF-CP) activity.A randomized, controlled, double-blind Phase III trial was conducted with PCT FFP or control FFP for therapeutic plasma exchange (TPE) in patients with thrombotic thrombocytopenic purpura (TTP). Owing to the rarity of this diagnosis, the trial was not powered to demonstrate small differences between treatment groups. Patients were treated with study FFP for a maximum of 35 days until remission was achieved (for a maximum of 30 daily study TPEs with no remission) plus an additional 5 days after remission.Among the 35 patients treated, the primary endpoint, remission within 30 days, was achieved by 14 of 17 (82%) PCT patients and 16 of 18 (89%) control patients (p = 0.658) The 90 percent confidence interval for treatment difference in remission rate for test - control was (-0.291 to 0.163). Time to remission, relapse rates, time to relapse, total volume and number of FFP units exchanged, and number of study TPEs were not significantly different between groups. Improvement in VWF-CP and inhibitors was similar for both groups. The overall safety profile of PCT FFP was similar to control FFP. No antibodies to amotosalen neoantigens were detected.The comparable results between treatment groups observed from this small trial suggest that TPE with PCT FFP was safe and effective for treatment of TTP.

    View details for DOI 10.1111/j.1537-2995.2006.00959.x

    View details for Web of Science ID 000240681000007

    View details for PubMedID 17002625

  • Anemia screening in elective surgery: Definition, significance and patients' interests ANESTHESIA AND ANALGESIA Shander, A., Javidroozi, M., Goodnough, L. T. 2006; 103 (3): 778-779
  • Clinical benefits and risks associated with epoetin and darbepoetin in patients with chemotherapy-induced anemia: A systematic review of the literature CLINICAL THERAPEUTICS Ross, S. D., Allen, I. E., Henry, D. H., Seaman, C., Sercus, B., Goodnough, L. T. 2006; 28 (6): 801-831


    Erythropoiesis-stimulating proteins (ESPs) are indicated for the treatment of chemotherapy-induced anemia (CIA). Evidence-based guidelines and systematic reviews of the management of CIA do not yet include all currently approved ESPs or all of the clinically relevant benefits and risks of ESPs.The aims of this work were to provide up-to-date assessments of the clinical efficacy and effectiveness (ie, transfusions and quality-of-life [QoL] benefits) and safety (ie, risk of venous thromboembolism [VTE] and all-cause or treatment-associated death) of epoetin-alfa, epoetin-beta, and darbepoetin-alfa for the treatment of CIA in cancer patients with hemoglobin<11 g/dL. We also considered the impact of differences in study design, patients, and treatments on the results.A systematic review of the literature was performed to identify and analyze English-language studies (controlled trials and prospective uncontrolled studies with >or=300 patients) published between 1980 and July 2005. The databases searched were MEDLINE and the Cochrane Library. Relevant abstracts from the last 2 annual meetings of the American Society of Clinical Oncology, American Society of Hematology, and European Society for Medical Oncology were also included. Studies were selected, using predefined eligibility criteria. Two reviewers had to agree on all included and excluded studies, and on all data extracted from each accepted study before they were entered into a relational database. Meta-analyses were performed to quantify benefit and risk outcomes.In total, 40 studies including 21,378 patients were eligible for analysis. Each ESP was found to have efficacy relative to standard care or placebo. The odds ratio (OR) for transfusions in studies of epoetin versus controls was 0.44 (95% CI, 0.35-0.55) and of darbepoetin versus controls was 0.41 (95% CI, 0.31-0.55). Patients receiving ESPs experienced a significant improvement in QoL; the mean difference in Functional Assessment of Cancer Therapy-Fatigue score for ESPs versus controls was 0.23 (95% CI, 0.10-0.36; P=0.001). The frequency of VTE and death was not significantly different between ESPs and control (VTE OR, 1.41 [95% CI, 0.81-2.47]; all-cause mortality OR, 1.00 [95% CI, 0.69-1.44]).This analysis of key clinical benefits and risks of epoetin and darbepoetin in the treatment of CIA found no clinically relevant differences between these drugs.

    View details for DOI 10.1016/j.clinthera.2006.06.003

    View details for Web of Science ID 000239100300001

    View details for PubMedID 16860166

  • Identification, diagnosis, and management of anemia in adult ambulatory patients treated by primary care physicians: evidence-based and consensus recommendations CURRENT MEDICAL RESEARCH AND OPINION Dubois, R. W., GOODNOUGH, L. T., Ershler, W. B., Van Winkle, L., Nissenson, A. R. 2006; 22 (2): 385-395


    Provide recommendations for the identification, diagnosis, and management of ambulatory patients with anemia.The RAND/UCLA Appropriateness Method was used to develop the recommendations. A literature review of anemia prevalence (based on a search of PubMed for the period 1990 to 2003), etiology, and treatment outcomes was reviewed by a panel comprised of nine physicians (six primary care, three specialists) who then rated 336 clinical scenarios and grouped them into three categories: 'appropriate', 'uncertain', or 'inappropriate'.Performing a complete blood count on a yearly basis was rated 'appropriate' for patients with an underlying chronic condition, for men > or = 50 years old, and for all women with no chronic condition on an every-5-years basis. Specific recommendations were made for five anemia management options (observation, referral, empiric trial of iron, transfusion, and erythropoietic growth factors). Recommendations for observation alone were based on age, gender, and hemoglobin level. Immediate referral to a gastroenterologist or hematologist for a work-up was rated 'inappropriate' in all cases. An empiric trial of iron was rated 'inappropriate' for women over age 40 and for all men. Recommendations on the use of erythropoietic growth factors were based on hemoglobin level and anemia symptoms ('appropriate' if Hb < 9.5 g/dL, or if Hb = 9.5-11.0 g/dL and anemia symptoms were present). Finally, recommendations about transfusion were based on the severity of anemia and the presence of cardiovascular disease ('appropriate' in patients > or = 70 years old and in those presenting with either symptoms of anemia or underlying cardiovascular disease). The recommendations did not address anemia related to nutritional deficiencies, cancer/chemotherapy, or chronic renal failure.Primary care physicians should obtain screening blood counts, perform diagnoses, and manage anemia in patient groups known to be at risk. These recommendations on the identification, diagnosis, and management of anemia represent an opportunity to improve outcomes in ambulatory patients with anemia.

    View details for DOI 10.1185/030079906X89720

    View details for Web of Science ID 000236302200017

    View details for PubMedID 16466611

  • Detection, evaluation, and management of anemia in the elective surgical patient ANESTHESIA AND ANALGESIA Goodnough, L. T., Shander, A., Spivak, J. L., Waters, J. H., Friedman, A. J., Carson, J. L., Keating, E. M., Maddox, T., Spence, R. 2005; 101 (6): 1858-1861


    The prevalence of anemia in elective surgical patients may be as frequent as 75% in certain populations. A national audit demonstrated that 35% of patients scheduled for joint replacement therapy have a hemoglobin <13 g/dL on preadmission testing. Standard practice currently consists of preadmission testing 3 to 7 days before an elective operative procedure, precluding the opportunity to effectively evaluate and manage a patient with unexpected anemia. Therefore, a standardized approach for the detection, evaluation, and management of anemia in the preoperative surgical setting was identified as an unmet medical need. To address this knowledge gap, we convened a panel of physicians to develop a clinical care pathway for anemia management in this setting. Elective surgery patients should receive a hemoglobin (Hgb) determination a minimum of 30 days before the scheduled surgical procedure. Because the identification and evaluation of anemia in this setting will assist in expedited diagnosis and treatment of underlying comorbidities and will improve patient outcomes, unexplained anemia (Hgb <12 g/dL for females and <13 g/dL for males) should cause elective surgery to be deferred until an evaluation can be performed.

    View details for DOI 10.1213/01.ANE.0000184124.29397.EB

    View details for Web of Science ID 000233512400055

    View details for PubMedID 16301274

  • Reduced risk of acute GVHD following mobilization of HLA-identical sibling donors with GM-CSF alone BONE MARROW TRANSPLANTATION Devine, S. M., Brown, R. A., Mathews, V., Trinkaus, K., Khoury, H., Adkins, D., Vij, R., Sempek, D., Graubert, T., Tomasson, M., GOODNOUGH, L. T., DiPersio, J. F. 2005; 36 (6): 531-538


    We retrospectively reviewed the results of transplanting peripheral blood progenitor cell (PBPC) allografts from HLA-matched sibling donors mobilized using various hematopoietic cytokines. Patients had received allografts mobilized with Granulocyte colony-stimulating factor (G-CSF) (G, N = 65) alone, G plus Granulocyte-macrophage colony stimulating factor (GM-CSF) (G/GM, N = 70), or GM-CSF alone at 10 or 15 microg/kg/day (GM, N = 10 at 10 microg/kg/day and 21 at 15 microg/kg/day). The CD34+ and CD3+ cell content of grafts were significantly lower following GM alone compared to G alone (P < 0.001 and 0.04, respectively). Nonhematopoietic toxicity observed in donors precluded dose escalation of GM-CSF beyond 10 microg/kg/day. Hematopoietic recovery was similar among all three groups. Grades II-IV acute graft-versus-host disease (GVHD) was observed in only 13% of patients in the GM alone group compared to 49 and 69% in the G alone or G/GM groups, respectively (P < 0.001). In a multivariate analysis, receipt of PBPC mobilized with GM alone was associated with a lower risk of grades II-IV acute GVHD (hazard ratio 0.21; 95% CI 0.073, 0.58) compared to G alone or G/GM. There were no differences in relapse risk or overall survival among the groups. Donor PBPC grafts mobilized with GM-CSF alone result in prompt hematopoietic engraftment despite lower CD34+ cell doses and may reduce the risk of grades II-IV acute GVHD following HLA-matched PBPC transplantation.

    View details for DOI 10.1038/sj.bmt.1705091

    View details for Web of Science ID 000231572200010

    View details for PubMedID 16025152

  • Autologous blood donation. Anesthesiology clinics of North America Goodnough, L. T. 2005; 23 (2): 263-?


    Preoperative autologous blood donation has become accepted as a standard practice in elective surgery. Subsequent improvements in blood safety and evolving surgical techniques resulting in less blood loss have caused a national decline in preoperative autologous blood donation by approximately 50%. Nevertheless, the continuing emergence of new pathogens and the potential for severe blood inventory shortages continue to give preoperative autologous blood donation an important role in blood conservation strategies.

    View details for PubMedID 15922898

  • Chimerism and clinical outcomes of 110 recipients of unrelated donor bone marrow transplants who underwent conditioning with low-dose, single-exposure total body irradiation and cyclophosphamide BLOOD Girgis, M., Hallemeier, C., Blum, W., Brown, R., Lin, H. S., Khoury, H., GOODNOUGH, L. T., Vij, R., Devine, S., Wehde, M., Postma, S., Oza, A., DiPersio, J., Adkins, D. 2005; 105 (8): 3035-3041


    We hypothesized that low-dose (550-cGy), single-exposure, high dose rate (30 cGy/min) total body irradiation (TBI) with cyclophosphamide as conditioning for HLA-compatible unrelated donor (URD) bone marrow transplantation (BMT) would result in donor chimerism (DC) with a low risk for serious organ toxicity and treatment-related mortality (TRM). Twenty-six patients with good risk diagnoses (acute leukemia in first complete remission [CR] and chronic-phase chronic myelogenous leukemia [CML]) and 84 with poor risk diagnoses underwent this regimen and URD BMT. Unsorted marrow nucleated cells were assessed for chimerism using VNTR probes. All DC occurred in 78 (86%) of 91 evaluable patients at 1 or more follow-up points. Graft failure occurred in 7 (7.7%) patients. Fatal organ toxicity occurred in only 2% of patients. TRM rates through 2 years of follow-up were 19% and 42% in those with good and poor risk diagnoses, respectively. Overall and disease-free survival rates in the good risk group were 47% and 40%, respectively, and in the poor risk group they were 25% and 21%, respectively, at a median follow-up for living patients of 850 days (range, 354-1588 days). This regimen resulted in 100% DC in most patients undergoing URD BMT with a relatively low risk for fatal organ toxicity and TRM.

    View details for DOI 10.1182/blood-2003-07-2346

    View details for Web of Science ID 000228344500015

    View details for PubMedID 15126314

  • Medical progress: Anemia of chronic disease NEW ENGLAND JOURNAL OF MEDICINE Weiss, G., GOODNOUGH, L. T. 2005; 352 (10): 1011-1023
  • Evidence-based and consensus recommendations for the non-approved use of recombinant human factor VIIa therapy Pharmacotherapeutics Shander A, Goodnough LT, Ratko T, Matuszewski K, Cohn S, Diringer M, Edmunds H, Lawson J, MacLaren R, Ness P, Shere-Wolfe R, Dubois R 2005: 644-658
  • Effects of pretransplantation treatment with rituximab on outcomes of autologous stem-cell transplantation for non-Hodgkin's lymphoma JOURNAL OF CLINICAL ONCOLOGY Hoerr, A. L., Gao, F., Hidalgo, J., Tiwari, D., Blum, K. A., Mathews, V., Adkins, D. R., Blum, W., Devine, S., Vij, R., GOODNOUGH, L. T., DiPersio, J. F., Khoury, H. J. 2004; 22 (22): 4561-4566


    To analyze the effects of preautografting treatment with rituximab (R) on stem-cell mobilization, post-transplantation complications, engraftment, disease-free survival, and overall survival in patients with non-Hodgkin's lymphoma (NHL).Single-institution retrospective comparative outcome analysis in a cohort of 273 relapsed chemosensitive NHL patients of whom 127 (47%) received R pretransplantation.R was administered a median of 3 months before autologous transplantation. When compared to the nonrituximab group, R patients were older (56 v 50 years; P < .001), and had delays in post-transplantation platelets recovery (39 v 27 days; P = .001). Pretransplantation R did not affect stem-cell mobilization, post-transplantation early complications, duration of hospitalization, or mortality rates at days 30 and 100. In contrast to patients with low-grade NHL, both disease-free and overall survival rates were significantly better when R was included in the pretransplantation salvage therapy for patients with intermediate-grade NHL.In this large, single-center retrospective analysis, pretransplantation treatment with R was associated with improved survival in patients with intermediate-grade NHL, at the price, however, of a delay in platelet engraftment.

    View details for DOI 10.1200/JCO.2004.05.035

    View details for Web of Science ID 000225175600018

    View details for PubMedID 15542807

  • Invited commentary. Annals of thoracic surgery Goodnough, L. T., Shander, A. 2004; 78 (5): 1554-1555

    View details for PubMedID 15511429

  • Supraventricular tachyarrhythmias after hematopoietic stem cell transplantation: incidence, risk factors and outcomes BONE MARROW TRANSPLANTATION Hidalgo, J. D., Krone, R., Rich, M. W., Blum, K., Adkins, D., Fan, M. Y., Brown, R., Devine, S., Graubert, T., Blum, W., Tomasson, M., GOODNOUGH, L. T., Vij, R., DiPersio, J., Khoury, H. 2004; 34 (7): 615-619


    Recent studies suggest that cancer patients may be at increased risk for supraventricular tachyarrhythmias (SVTA). We have observed clinically significant SVTA in patients undergoing hematopoietic stem cell transplantation occurring at a median of 6 days post transplant, manifesting as atrial fibrillation/flutter or regular narrow-complex tachycardia and persisting for a median of 3 days (range, 0-8). All patients received aggressive medical therapy and/or electrical cardioversion to restore sinus rhythm and to re-establish hemodynamic stability. Non-Hodgkin's lymphoma (NHL) was the most common diagnosis (53%), and a case control analysis in those patients demonstrated that SVTA occurred in 12% of patients and was associated with older age and pre-existing cardiac conditions. In conclusion, patients undergoing HSCT are at moderate risk for developing SVTA, particularly older patients with a diagnosis of NHL. These arrhythmias are clinically significant, and are a marker for increased mortality and prolonged hospital stay. Additional studies are needed to identify high-risk patients who may benefit from prophylactic anti-arrhythmic therapy.

    View details for DOI 10.1038/sj.bmt.1704623

    View details for Web of Science ID 000223884900009

    View details for PubMedID 15258562

  • Transfusion medicine service policies for recombinant factor VIIa administration TRANSFUSION Goodnough, L. T., Lublin, D. M., Zhang, L., Despotis, G., Eby, C. 2004; 44 (9): 1325-1331


    Recombinant FVIIa (rFVIIa) has been approved for treatment of bleeding in hemophilia patients with inhibitors. It has also been successfully used in nonhemophilia patients with acquired antibodies against FVIII (acquired hemophilia). Pharmacological doses of rFVIIa have been found to enhance the thrombin generation on already activated platelets and, therefore, may also likely be of benefit in providing hemostasis in other situations characterized by profuse bleeding and impaired thrombin generation, such as patients with thrombocytopenia and in those with functional platelet defects. Additionally, it has been used successfully in a variety of less well-characterized bleeding situations, as well as in patients with impaired liver function. To date, case reports, anecdotal experience, and limited clinical trials describe these uses; data from randomized clinical trials are limited. Because of the recent trends in rFVIIa usage in non-approved settings among physicians from various disciplines, significant concerns about its safety, efficacy, and costs have arisen. Additionally, dosing of rFVIIa for these potentially broad clinical applications is not standardized. Currently, the decision on when and where to use rFVIIa for patients with uncontrolled bleeding continues to be one that must be made by individual physicians, assisted by their hospital pharmacotherapeutics and transfusion committees.

    View details for Web of Science ID 000223575100010

    View details for PubMedID 15318856

  • Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial BLOOD McCullough, J., Vesole, D. H., Benjamin, R. J., Slichter, S. J., Pineda, A., Snyder, E., Stadtmauer, E. A., Lopez-Plaza, I., Coutre, S., Strauss, R. G., GOODNOUGH, L. T., Fridey, J. L., Raife, T., Cable, R., Murphy, S., Howard, F., Davis, K., Lin, J. S., Metzel, P., Corash, L., Koutsoukos, A., Lin, L., Buchholz, D. H., Conlan, M. G. 2004; 104 (5): 1534-1541


    We report a transfusion trial of platelets photochemically treated for pathogen inactivation using the synthetic psoralen amotosalen HCl. Patients with thrombocytopenia were randomly assigned to receive either photochemically treated (PCT) or conventional (control) platelets for up to 28 days. The primary end point was the proportion of patients with World Health Organization (WHO) grade 2 bleeding during the period of platelet support. A total of 645 patients (318 PCT and 327 control) were evaluated. The primary end point, the incidence of grade 2 bleeding (58.5% PCT versus 57.5% control), and the secondary end point, the incidence of grade 3 or 4 bleeding (4.1% PCT versus 6.1% control), were equivalent between the 2 groups (P =.001 by noninferiority). The mean 1-hour posttransfusion platelet corrected count increment (CCI) (11.1 x 10(3) PCT versus 16.0 x 10(3) control), average number of days to next platelet transfusion (1.9 PCT versus 2.4 control), and number of platelet transfusions (8.4 PCT versus 6.2 control) were different (P <.001). Transfusion reactions were fewer following PCT platelets (3.0% PCT versus 4.4% control; P =.02). The incidence of grade 2 bleeding was equivalent for PCT and conventional platelets, although posttransfusion platelet count increments and days to next transfusion were decreased for PCT compared with conventional platelets.

    View details for Web of Science ID 000223544000052

    View details for PubMedID 15138160

  • Blood and blood conservation: A national perspective JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA Goodnough, L. T. 2004; 18 (4): 6S-11S

    View details for DOI 10.1053/j.jvca.2004.05.001

    View details for Web of Science ID 000224024500002

    View details for PubMedID 15368198

  • Effect of plasma exchange on plasma ADAMTS13 metalloprotease activity, inhibitor level, and clinical outcome in patients with idiopathic and nonidiopathic thrombotic thrombocytopenic purpura BLOOD Zheng, X. L., Kaufman, R. M., GOODNOUGH, L. T., Sadler, J. E. 2004; 103 (11): 4043-4049


    Therapeutic plasma exchange is an effective empiric treatment for thrombotic thrombocytopenic purpura (TTP), but how therapy affects the level of a disintegrin and metalloprotease with thrombospondin type 1 motif 13 (ADAMTS13) or inhibitor has not been reported in many patients. We prospectively analyzed ADAMTS13 activity and inhibitor levels in 37 adults with TTP. ADAMTS13 level at presentation was lower than 5% in 16 of 20 patients with idiopathic TTP and in none of 17 patients with TTP associated with hematopoietic stem cell transplantation, cancer, drugs, or pregnancy (P <.00001). Seven of the 16 patients with ADAMTS13 activity lower than 5% ( approximately 44%) had inhibitors. For 8 patients followed serially with ADAMTS13 activity lower than 5% but no inhibitor at presentation, plasma exchange led to complete clinical remission and a rise in ADAMTS13 level. In contrast, 4 patients with low ADAMTS13 activity but high-titer inhibitor (> 5 units/mL) had neither a rise in ADAMTS13 activity nor a reduction in the inhibitor titer: 3 had recurrent disease and 1 died. Among 17 patients with AD-AMTS13 activity at presentation higher than 25%, 10 died. Mortality rate for idiopathic TTP was 15%, whereas mortality for nonidiopathic TTP was 59% (P <.02). We conclude that assays of ADAMTS13 activity and inhibitors in addition to the clinical categories (idiopathic TTP and nonidiopathic TTP) are predictive of outcome and may be useful to tailor patient treatment.

    View details for DOI 10.1182/blood-2003-11-4035

    View details for Web of Science ID 000221657600017

    View details for PubMedID 14982878

  • Outcomes of adults with acute myelogenous leukemia in remission given 550 cGy of single-exposure and total body irradiation, cyclophosphamide, unrelated donor bone marrow transplants BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION Hallemeier, C., Girgis, M., Blum, W., Brown, R., Khoury, H., GOODNOUGH, L. T., Vij, R., Devine, S., Wehde, M., Postma, S., Lin, H. S., Dipersio, F., Adkins, D. 2004; 10 (5): 310-319


    On the basis of observations from dog models and human studies, we hypothesized that a low-dose (550 cGy), single-exposure total body irradiation (TBI)-based regimen would result in improved survival when given to adult patients with acute myelogenous leukemia (AML) who were undergoing unrelated donor bone marrow transplantation in complete remission (CR). The regimen consisted of single exposure (550 cGy) of TBI given at a high dose rate (30 cGy/min) and cyclophosphamide. Graft-versus-host disease prophylaxis consisted of cyclosporine, methotrexate, and corticosteroids. Thirty-two consecutive adult patients (median age, 47 years) with AML in CR (15 in CR 1 and 17 in CR > or =2) were treated. Sixteen patients (50%) were alive and in remission at last follow-up (median, 2.2 years; range, 0.6-4.0 years). Kaplan-Meier estimates of overall and leukemia-free survival at 3 years were 55% +/- 14% (mean +/- SE) and 57% +/- 14% in CR 1 patients and were both 39% +/- 12% in CR > or =2 patients. Transplant-related mortality was 13% for patients in CR 1 and 41% for those in CR > or =2. Only 1 patient (3%) experienced fatal regimen-related organ toxicity, and only 1 had grade III or IV acute graft-versus-host disease. Graft failure was not observed. Relapse occurred in 22% of patients. This low-dose (550 cGy), single-exposure TBI-based regimen resulted in good survival and a low risk of fatal regimen-related organ toxicity in adult patients with AML who underwent unrelated donor bone marrow transplantation in CR.

    View details for DOI 10.1016/j.bbmt.2003.12.002

    View details for Web of Science ID 000221485700003

    View details for PubMedID 15111930

  • Anemia and its clinical consequences in patients with chronic diseases. American journal of medicine Goodnough, L. T., Nissenson, A. R. 2004; 116: 1S-2S

    View details for PubMedID 15050881

  • Prevalence and outcomes of anemia in rheumatoid arthritis: a systematic review of the literature. American journal of medicine Wilson, A., Yu, H., Goodnough, L. T., Nissenson, A. R. 2004; 116: 50S-57S


    Anemia is a common comorbidity in individuals with rheumatoid arthritis (RA). In fact, anemia of the type characterized by low serum iron concentrations in conjunction with adequate iron stores is frequently associated with RA and has served as a model for anemia of chronic disease. A systematic search of the scientific literature published since January 1966 identified 19 articles that reported findings on either the prevalence of anemia in patients with RA or outcomes for patients with anemia and RA. Ten articles addressed the prevalence of anemia in patients with RA. Estimates of the prevalence of mild anemia ranged between 33% and 60%; however, the 2 studies that examined demographics in patients with RA did not identify subpopulations at particular risk for anemia. Twelve articles assessed the impact of the resolution of anemia on symptoms and quality of life (QOL) in patients with RA. For many of the parameters assessed-including swollen, painful, and tender joints, pain, muscle strength, and energy levels-a positive correlation was observed between improvement of symptoms and the resolution of anemia. In addition, 2 studies reported a significant improvement in QOL scores in patients with RA who experienced a response to treatment for anemia. These results suggest that (1) patients with RA who have anemia are likely to have more severe joint disease and (2) if the anemia is successfully treated, the joint disease will likely respond to treatment as well. Whether improvements in QOL and/or joint symptoms occur with improvement of anemia, independent of other signs of an overall response to RA therapy, remains to be determined.

    View details for PubMedID 15050886

  • Joint ASH and AABB educational session. Hematology / the Education Program of the American Society of Hematology. American Society of Hematology. Education Program Goodnough, L. T., Hewitt, P. E., Silliman, C. C. 2004: 457-472


    In the vein-to-vein flow of blood from donor to patient, the role of the transfusion medicine specialist has become increasingly centered at the bedside. Three clinically centered issues in blood safety and in blood conservation are presented in this chapter. In Section I, Dr. Patricia Hewitt presents the epidemiologic and clinical evidence regarding new variant Creutzfeldt-Jakob disease (nvCJD) in the UK and its relevance to transfusion medicine. Lessons learned from the responses by the National Blood Service to this crisis are discussed, particularly in the context of recent evidence of a case of vCJD transmission by blood transfusion and a second case of apparent transmission of abnormal prion protein without development of clinical illness. In Section II, Dr. Christopher Silliman and his colleagues summarize recent knowledge gained regarding transfusion-related acute lung injury (TRALI), which is now the leading cause of transfusion-related mortality. Two different etiologies have been proposed: a single antibody-medicated event, involving anti-HLA Class I and Class II, or anti-granulocyte antibodies; and a two-event model, which includes the clinical condition of the patient resulting in pulmonary endothelial activation and neutrophil sequestration. The second event is the transfusion of a biologic response modifier (lipids or antibodies) in the blood component that activates primed neutrophils. Prevention, clinical treatment, and proposed definition of TRALI are discussed. In Section III, Dr. Lawrence Goodnough and colleagues present a transfusion medicine service approach to the utilization of recombinant factor VIIa (rFVIIa) in non-approved clinical settings. rFVIIa has a potential role as a hemostatic intervention in a variety of clinical settings, yet few clinical trials have been completed to date to guide indications for its use. The policies presented here are those in place at the authors' medical center, and will undergo periodic review and revision as relevant new information and data are generated.

    View details for PubMedID 15561698

  • Experiences with recombinant human factor VIIa in patients with thrombocytopenia SEMINARS IN HEMATOLOGY GOODNOUGH, L. T. 2004; 41 (1): 25-29


    In addition to its proven benefits in hemophilia, recombinant factor VIIa (rFVIIa), is predicted to be of benefit in other situations characterized by profuse bleeding and impaired thrombin generation, due to its ability to enhance thrombin generation on already activated platelets. This article reviews studies that have described the use of rFVIIa in a variety of clinical settings involving refractory hemorrhage. Ex vivo studies revealed that, at pharmacologic doses, rFVIIa significantly shortened the lag time of thrombin generation, resulting in the formation of more thrombin during the initial coagulation process. Anecdotal clinical reports describe how rFVIIa has been used to resolve serious bleeding in thrombocytopenic patients and a study showed how rFVIIa positively reduced bleeding time in 52% of bleeding wounds in patients with thrombocytopenia. It is concluded that rFVIIa has a potential role in patients with thrombocytopenia and clinical hemorrhage.

    View details for DOI 10.1053/j.seminhematol.2003.11.006

    View details for Web of Science ID 000189079100007

    View details for PubMedID 14872417

  • Autoantibody formation after alloimmunization: are blood tranfusions a risk factor for autoimmune hemolytic anemia? TRANSFUSION Young, P. P., Uzieblo, A., Trulock, E., Lublin, D. M., Goodnough, L. T. 2004; 44 (1): 67-72


    The development of RBC autoantibodies resulting from or associated with allogeneic blood transfusions (i.e., RBC autoimmunization) is not a well-recognized complication of RBC transfusions.T: he presentation, laboratory evaluation, clinical course, and management of two patients whose autoimmune hemolytic anemia followed allogeneic blood transfusion and occurred in association with the development of one or more alloantibodies is described. A retrospective analysis was performed of our blood-bank records over 1 year to determine the frequency of RBC autoimmunization associated with alloimmunization.Out of 2618 patients who had a positive DAT or IAT, 121 were identified with RBC autoantibodies; 41 of these patients had both allo- and autoantibodies to RBC antigens, whereas the remainder, 80, had only autoantibodies. At least 34 percent (12/41) of these patients (none with hemoglobinopathy) developed their autoantibodies in temporal association with alloimmunization after recent blood transfusion(s).RBC autoimmunization and the development of autoimmune hemolytic anemia should be recognized as a complication of allogeneic blood transfusion. The need for additional blood transfusion was successfully avoided in one patient by treatment with recombinant human EPO and corticosteroid therapy. Once RBC autoimmunization is identified, subsequent management should incorporate a strategy that minimizes subsequent exposure to allogeneic blood.

    View details for Web of Science ID 000187896500011

    View details for PubMedID 14692969

  • Risks of blood transfusion CRITICAL CARE MEDICINE Goodnough, L. T. 2003; 31 (12): S678-S686


    To review the current status of risks of blood transfusion. DATA SOURCES, EXTRACTIONS, AND SYNTHESIS: English-speaking literature, literature search using key works, human data, and follow-up with key bibliographic citations.Substantial advances have been achieved in blood safety during the last 20 yrs, particularly for transfusion-transmitted viral infections. Currently, the most serious known risks from blood transfusion are administrative error (leading to ABO-incompatible blood transfusion), transfusion-related acute lung injury, and bacterial contamination in platelet products. Emerging pathogens, such as West Nile virus infection emphasize the need for implementation of proactive strategies, such as pathogen inactivation technologies, as well as reactive strategies, such as nucleic acid testing, to ensure continued advances in blood safety.

    View details for DOI 10.1097/01.CCM.0000100124.50579.D9

    View details for Web of Science ID 000187636200006

    View details for PubMedID 14724466

  • Hydroxychloroquine for the prevention of acute graft-versus-host disease after unrelated donor transplantation BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION Khoury, H., Trinkaus, K., Zhang, M. J., Adkins, D., Brown, R., Vij, R., GOODNOUGH, L. T., Ma, M. K., McLeod, H. L., Shenoy, S., Horowitz, M., DiPersio, J. F. 2003; 9 (11): 714-721


    Hydroxychloroquine (HCQ) is an immunosuppressive agent that interferes with antigen presentation and with activity against graft-versus-host disease (GVHD). In a phase II trial assessing the GVHD prophylactic effects of HCQ, 51 consecutive unrelated donor transplant recipients received HCQ in addition to cyclosporin A, methylprednisolone, and methotrexate. HCQ was initiated on pretransplantation day -21 at 800 mg/d and continued until day +100 after transplantation. HCQ was extremely well tolerated and was not associated with side effects. Pharmacokinetic analyses demonstrated large inter- and intrapatient variability. The addition of HCQ did not affect posttransplantation immune recovery. Grade II to IV acute GVHD was observed in 56% of patients, and grade III and IV GVHD was observed in 17%. Day +100 mortality was 22%. When compared with a matched cohort of patients reported to the International Bone Marrow Transplant Registry, patients receiving HCQ had comparable cumulative incidences of grade II to IV acute GVHD. However, lower incidences of grades III and IV GVHD and better GVHD-free survival were observed in HCQ-treated patients (P =.01). We conclude that prophylactic HCQ is well tolerated and associated with a low incidence of severe acute GVHD. An ongoing placebo-controlled randomized trial will further determine what role HCQ plays in preventing GVHD after allografting.

    View details for DOI 10.1016/S1083-8791(03)00294-5

    View details for Web of Science ID 000187010600007

    View details for PubMedID 14652855

  • Long-term outcomes of allogeneic stem cell transplant recipients after calcineurin inhibitor-induced neurotoxicity BRITISH JOURNAL OF HAEMATOLOGY Chohan, R., Vij, R., Adkins, D., Blum, W., Brown, R., Tomasson, M., Devine, S., Graubert, T., GOODNOUGH, L. T., DiPersio, J. F., Khoury, H. 2003; 123 (1): 110-113


    Calcineurin inhibitor-induced central nervous system toxicities are uncommon and often resolve after discontinuation of the offending drug. The long-term outcome of these patients is, however, unknown. Resolution of symptoms occurred in 70% of 30 allografted recipients who developed calcineurin inhibitor-induced neurotoxicity. When patients were rechallenged with the same or a different calcineurin inhibitor, symptoms recurred in 41%, leading to permanent discontinuation of the drug. De novo or progressive acute graft-versus-host disease (GVHD) was observed in 54% of patients at a median of 7 d (range 1-70 d) after initial onset of neurotoxicity. The prognosis was grim, with 24 (80%) of these patients dying a median 33 d after the onset of neurotoxicity (range 2-594 d). GVHD and/or infection occurred in 54% and were the most common primary causes of death. We conclude that calcineurin inhibitor-induced neurotoxicity is frequently reversible but associated with a poor prognosis.

    View details for Web of Science ID 000185595500015

    View details for PubMedID 14510951

  • Low-dose short-course intravenous ganciclovir as pre-emptive therapy for CMV viremia post allo-PBSC transplantation BONE MARROW TRANSPLANTATION Vij, R., Khoury, H., Brown, R., GOODNOUGH, L. T., Devine, S. M., Blum, W., Adkins, D., DiPersio, J. F. 2003; 32 (7): 703-707


    In contrast to allogeneic bone marrow transplantation (allo-BMT), there is a paucity of data on cytomegalovirus (CMV) infection and preemptive therapy (PT) strategies following allogeneic peripheral blood stem cell (allo-PBSC) transplantation. We report here on the patterns of CMV infection in a cohort of 225 patients following sibling donor allo-PBSC transplantation. In an attempt to reduce neutropenia, we used intravenous low-dose short-course (LDSC) ganciclovir (GCV) 5 mg/kg once daily for 21 days as preemptive therapy. A total of 165 recipient-donor pairs were CMV seropositive. An initial episode of viremia (detected by shell vial/tube culture) occurred in 75/165 (45%) at a median of day +35 (17-445) post allo-PBSC. In all, 58 patients received PT with LDSC GCV. Among 58, 55 (94%) completed the 21-day course of PT. A second episode of viremia occurred in 19/58 (33%) at day+80 (50-174) and a third episode in 5/58 (9%) at day+134 (103-218). Among patients receiving LDSC GCV, 5/58(9%) developed disease (four pneumonia, one colitis) at day+211 (63-487). No patient on LDSC GCV exhibited a decline in their ANC below 500/microl and none required growth factors. LDSC GCV is extremely well tolerated and cost-effective as PT for CMV viremia following allo-PBSC transplantation.

    View details for DOI 10.1038/sj.bmt.1704216

    View details for Web of Science ID 000185335100010

    View details for PubMedID 13130318

  • Patient safety and blood transfusion: New solutions TRANSFUSION MEDICINE REVIEWS Dzik, W. H., Corwin, H., GOODNOUGH, L. T., Higgins, M., Kaplan, H., Murphy, M., Ness, P., Shulman, I. A., Yomtovian, R. 2003; 17 (3): 169-180


    Current risk from transfusion is largely because of noninfectious hazards and defects in the overall process of delivering safe transfusion therapy. Safe transfusion therapy depends on a complex process that requires integration and coordination among multiple hospital services including laboratory medicine, nursing, anesthesia, surgery, clerical support, and transportation. The multidisciplinary hospital transfusion committee has been traditionally charged with oversight of transfusion safety. However, in recent years, this committee may have been neglected in many institutions. Resurgence in hospital oversight of patient safety and transfusion efficacy is an important strategy for change. A new position, the transfusion safety officer (TSO), has been developed in some nations to specifically identify, resolve, and monitor organizational weakness leading to unsafe transfusion practice. New technology is becoming increasingly available to improve the performance of sample labeling and the bedside clerical check. Several technology solutions are in various stages of development and include wireless handheld portable digital assistants, advanced bar coding, radiofrequency identification, and imbedded chip technology. Technology-based solutions for transfusion safety will depend on the larger issue of the technology for patient identification. Devices for transfusion safety hold exciting promise but need to undergo clinical trials to show effectiveness and ease of use. Technology solutions will likely require integration with delivery of pharmaceuticals to be financially acceptable to hospitals.

    View details for DOI 10.1016/S0887-7963(03)00017-8

    View details for Web of Science ID 000184367400001

    View details for PubMedID 12881778

  • Anemia - Not just an innocent bystander? ARCHIVES OF INTERNAL MEDICINE Nissenson, A. R., GOODNOUGH, L. T., Dubois, R. W. 2003; 163 (12): 1400-1404

    View details for Web of Science ID 000183705400003

    View details for PubMedID 12824088

  • Recombinant human thrombopoietin augments mobilization of peripheral blood progenitor cells for autologous transplantation BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION Linker, C., Anderlini, P., Herzig, R., Christiansen, N., Somlo, G., Bensinger, W., Fay, J., Lynch, J. P., GOODNOUGH, L. T., Ashby, M., Benyunes, M. C., Jones, D. V., Yang, T. A., MILLER, L. L., Weaver, C. 2003; 9 (6): 405-413


    This study assessed the ability of various schedules of recombinant human thrombopoietin (rhTPO) to enhance mobilization of peripheral blood progenitor cells (PBPCs) in 134 patients with cancer undergoing high-dose chemotherapy and autologous PBPC transplantation. Patients received the study drug on days 1, 3, and 5 before initiation of granulocyte colony-stimulating factor (G-CSF) 10 microg/kg/day on day 5 and pheresis starting on day 9. Randomly assigned treatments on days 1, 3, and 5 were: group 1 (n=27) placebo, placebo, rhTPO 1.5 microg/kg; group 2 (n=27) rhTPO 1.5 microg/kg, placebo, placebo; groups 3 (n=28) and 4 (n=22) rhTPO 0.5 microg/kg on all 3 treatment days; and group 5 (n=30) placebo on all 3 treatment days. After high-dose chemotherapy and PBPC transplantation, groups 1 through 4 received rhTPO 1.5 microg/kg days 0, +2, +4, and +6 with either G-CSF 5 microg/kg/day (groups 1-3) or granulocyte-macrophage colony-stimulating factor 250 microg/m(2)/day (group 4). Group 5 received placebo plus G-CSF 5 microg/kg/day. The addition of rhTPO to G-CSF increased median CD34+ cell yield/pheresis in cohorts in which rhTPO was started before day 5, with higher yields in groups 2 (2.67 x 10(6)/kg) and groups 3 and 4 (3.10 x 10(6)/kg) than in group 1 (1.86 x 10(6)/kg) or group 5 (1.65 x 10(6)/kg) (P=.006 across groups). Comparing rhTPO to placebo, higher percentages of patients achieved the minimum yield of CD34+ > or =2 x 10(6)/kg (92% v 75%; P=.050) as well as the target yield of CD34+ > or =5 x 10(6)/kg (73% v 46%; P= .041). rhTPO-treated patients required fewer phereses to achieve minimum (P= .011) and target (P= .015) CD34+ cell values. rhTPO given after transplantation did not speed platelet recovery. No neutralizing antibodies were observed. We conclude that rhTPO can safely enhance mobilization of PBPC, reduce the number of leukapheresis, and allow more patients to meet minimal cell yield requirements to receive high-dose chemotherapy with PBPC transplantation.

    View details for DOI 10.1016/S1083-8791(03)00101-0

    View details for Web of Science ID 000183955700007

    View details for PubMedID 12813449

  • Primary amyloidosis patients with significant organ dysfunction tolerate autologous transplantation after conditioning with single-dose total body irradiation alone: A feasibility study BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION Blum, W., Khoury, H., Lin, H. S., Vij, R., GOODNOUGH, L. T., Devine, S., DiPersio, J., Adkins, D. 2003; 9 (6): 397-404


    High-dose melphalan has been commonly used as conditioning for amyloidosis with considerable toxicity. We hypothesized that the novel conditioning regimen of 550 cGy total body irradiation (TBI) alone for autologous peripheral blood stem cell transplantation would have reduced organ toxicity and thus permit safer transplantation of primary amyloidosis patients, even those with poor risk disease. The comprehensive regimen included pretransplantation chemotherapy, single-dose TBI alone (550 cGy at 30 cGy/min) conditioning, and post-transplantation interferon-alpha maintenance. Thirteen patients were enrolled in this feasibility study. Patients with multiorgan involvement were included; 10 patients had poor or intermediate risk disease. Cardiac toxicity was significant. Treatment-related mortality through 100 days post-transplantation was 15% and was caused by cardiac mortality. One patient died from arrhythmia after receiving TBI; 2 patients had grade IV cardiac toxicity (with subsequent complete recovery). One patient died 1 month after mobilization from progressive cardiomyopathy and never received conditioning. However, noncardiac organ toxicity was mild. No patient required parenteral nutrition support; no patient developed mucositis; and no patient experienced gastrointestinal bleeding following transplantation. The complete hematologic remission rate was 45%, with pretransplantation chemotherapy being the most active part of the regimen. Survival estimates from enrollment to 1 and 2 years post-transplantation were 66% and 47%, respectively. Causes of death were disease progression (6), myelodysplasia (1), arrhythmia following TBI (1), and congestive heart failure after mobilization (1). In this cohort of primary amyloidosis patients, the transplantation regimen of 550 cGy TBI was feasible and associated with modest treatment-related mortality. Efficacy with TBI conditioning may be reduced compared with high-dose melphalan, but this should be explored in a future trial with a larger cohort of patients.

    View details for DOI 10.1016/S1083-8791(03)00106-X

    View details for Web of Science ID 000183955700006

    View details for PubMedID 12813448

  • Autologous blood procurement - acute normovolemic hemodilution vs. preoperative autologous blood donation ZENTRALBLATT FUR CHIRURGIE Goodnough, L. T. 2003; 128 (6): 462-467


    Autologous blood procurement remains in evolution. Interest in preoperative autologous blood donation (PAD) increased substantially in the 1980's due to the recognition that HIV was transmissible by blood. Concomitant with increased blood safety, however, PAD activity has declined approximately 40% since 1992. Reasons for this decline are unclear; patients may feel more comfortable with issues regarding blood safety, but associated costs and discard rates of up to 50% of blood units are other important factors. An alternate strategy is acute normovolemic hemodilution (ANH), which has the advantages of lower costs along with no wastage of blood units. A further advantage is that since ANH units never leave the patient's bedside, there is no possibility of an administrative error that could lead to ABO-related hemolysis (as could occur with PAD units stored in the blood bank). Concerns regarding the adequacy of national blood inventories may restimulate interest in autologous blood procurement, independent of issues regarding blood risks or costs.

    View details for Web of Science ID 000184304400003

    View details for PubMedID 12865950

  • The use of erythropoietin to increase red cell mass CANADIAN JOURNAL OF ANAESTHESIA-JOURNAL CANADIEN D ANESTHESIE Goodnough, L. T. 2003; 50 (6): S10-S18

    View details for Web of Science ID 000184150200003

    View details for PubMedID 14629048

  • Bloodless medicine: clinical care without allogeneic blood transfusion TRANSFUSION GOODNOUGH, L. T., Shander, A., Spence, R. 2003; 43 (5): 668-676

    View details for Web of Science ID 000182418300022

    View details for PubMedID 12702192

  • Transfusion medicine: looking to the future LANCET GOODNOUGH, L. T., Shander, A., Brecher, M. E. 2003; 361 (9352): 161-169


    The evolution of transfusion medicine into a clinically oriented discipline emphasising patient care has been accompanied by challenges that need to be faced as specialists look to the future. Emerging issues that affect blood safety and blood supply, such as pathogen inactivation and more stringent donor screening questions, bring new pressures on the availability of an affordable blood supply. Imminent alternatives for management of anaemia, such as oxygen carriers, hold great promise but, if available, will require close oversight. With current estimates of HIV or hepatitis C viral (HCV) transmission approaching one in 2000000 units transfused, keeping to a minimum bacterial contamination of platelet products (one in 2000) and errors in transfusion, with its estimated one in 800000 mortality rate, assume great urgency. Finally, serious difficulties in blood safety and availability for poor, developing countries require innovative strategies and commitment of resources.

    View details for Web of Science ID 000180428000026

    View details for PubMedID 12531595

  • Evolution in alternatives to blood transfusion. hematology journal Goodnough, L. T., Shander, A. 2003; 4 (2): 87-91

    View details for PubMedID 12750725

  • The rise and fall of preoperative autologous blood donation (editorial). Transfusion. 2001;41:1459-62. Transfusion Brecher, M. E., Goodnough, L. T. 2002; 42 (12): 1618-1622

    View details for PubMedID 12473149

  • Issues in the management of cancer-related thrombocytopenia ONCOLOGY-NEW YORK Goodnough, L. T., Dipersio, J. F. 2002; 16 (11): 1558-1567


    Thrombocytopenia remains a significant clinical problem for patients with cancer. Management approaches include watchful waiting, platelet transfusions, and the use of pharmacologic agents. Although platelet transfusion remains the gold standard for prophylaxis and treatment of thrombocytopenia, this approach is associated with transfusion-transmitted disease, infection, and platelet refractoriness. Because of these complications and the expense of platelet therapy, recent studies have examined the clinical evidence supporting the widely used platelet transfusion trigger of 20,000 cells/microL and found that values of 5,000 to 10,000 cells/microL are safe for selected patients. Several investigational agents offer promise for treatment of thrombocytopenia in patients undergoing myelosuppressive and myeloablative therapy. These agents include recombinant human interleukin-11, recombinant human thrombopoietin, and c-Mpl ligand mimetics.

    View details for Web of Science ID 000179553800027

    View details for PubMedID 12469931

  • Treatment of critical bleeding in the future intensive care unit INTENSIVE CARE MEDICINE GOODNOUGH, L. T. 2002; 28: S221-S221

    View details for DOI 10.1007/s00134-002-1468-2

    View details for Web of Science ID 000180826500001

    View details for PubMedID 12583409

  • Fatal thrombosis after administration of activated prothrombin complex concentrates in a patient supported by extracorporeal membrane oxygenation who had received activated recombinant factor VII JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY Bui, J. D., Despotis, G. D., Trulock, E. P., PATTERSON, G. A., Goodnough, L. T. 2002; 124 (4): 852-854

    View details for DOI 10.1067/mtc.2002.126038

    View details for Web of Science ID 000178405700032

    View details for PubMedID 12324751

  • Indications for red cell transfusion VOX SANGUINIS Goodnough, L. T. 2002; 83: 7-9

    View details for Web of Science ID 000178810300003

    View details for PubMedID 12617092

  • Acute normovolemic hemodilution VOX SANGUINIS Goodnough, L. T. 2002; 83: 211-215

    View details for Web of Science ID 000178810300051

    View details for PubMedID 12617140

  • Polymerized bovine hemoglobin solution as a replacement for allogeneic red blood cell transfusion after cardiac surgery: Results of a randomized, double-blind trial JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY Levy, J. H., GOODNOUGH, L. T., Greilich, P. E., Parr, G. V., Stewart, R. W., Gratz, I., Wahr, J., Williams, J., Comunale, M. E., Doblar, D., Silvay, G., Cohen, M., Jahr, J. S., Vlahakes, G. J. 2002; 124 (1): 35-42


    Blood loss leading to reduced oxygen-carrying capacity is usually treated with red blood cell transfusions. This study examined the hypothesis that a hemoglobin-based oxygen-carrying solution can serve as an initial alternative to red blood cell transfusion.In a randomized, double-blind efficacy trial of HBOC-201, a total of 98 patients undergoing cardiac surgery and requiring transfusion were randomly assigned to receive either red blood cell units or HBOC-201 (Hemopure; Biopure Corporation, Cambridge, Mass) for the first three postoperative transfusions. Patients were monitored before and after transfusion, at discharge, and at 3 to 4 weeks after the operation for subsequent red blood cell use, hemodynamics, and clinical laboratory parameters.The use of HBOC-201 eliminated the need for red blood cell transfusions in 34% of cases (95% confidence interval 21%-49%). Patients in the HBOC group received a mean of 1.72 subsequent units of red blood cells; those who received red blood cells only received a mean of 2.19 subsequent units (P =.05). Hematocrit values were transiently lower in the HBOC group but were similar in the two groups at discharge and follow-up. Oxygen extraction was greater in the HBOC group (P =.05). Mean increases in blood pressure were greater in the HBOC group, but not significantly so.HBOC-201 may be an initial alternative to red blood cell transfusions for patients with moderate anemia after cardiac surgery. In a third of cases, HBOC-201 eliminated the need for red blood cell transfusion, although substantial doses were needed to produce this modest degree of blood conservation.

    View details for DOI 10.1067/mtc.2002.121505

    View details for Web of Science ID 000176808200008

    View details for PubMedID 12091806

  • Low-dose (550 cGy), single-exposure total body irradiation and cyclophosphamide: Consistent, durable engraftment of related-donor peripheral blood stem cells with low treatment-related mortality and fatal organ toxicity BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION Blum, W., Brown, R., Lin, H. S., Zehnbauer, B., Khoury, H., GOODNOUGH, L. T., Westervelt, P., Vij, R., DiPersio, J., Adkins, D. 2002; 8 (11): 608-618


    On the basis of observations of dog models and from earlier studies with humans, we hypothesized that a low-dose (550 cGy) TBI-based conditioning regimen would result in sustained engraftment of HLA-matched sibling peripheral blood stem cells (PBSC) with low treatment-related mortality (TRM) and low serious organ toxicity if the TBI was given as a single dose and at a high dose rate. The regimen included 550 cGy TBI administered as a single dose at 30 cGy/min and cyclophosphamide. Cyclosporine was given as GVHD prophylaxis. Twenty-seven good-risk (acute leukemia in first remission and chronic-phase chronic myelogenous leukemia) and 53 poor-risk (other) patients were accrued. Complete donor engraftment occurred in 93% to 100% of evaluable patients at each scheduled assessment and was durable through 4 years. Mixed chimerism (50% to 98% donor) was observed in 9 patients (11%). Without further intervention, all patients had complete donor engraftment on subsequent assessments. Graft failure did not occur. TRM through at least 2 years was 7% in the good-risk and 19% in the poor-risk diagnostic groups. Grade 4 (fatal) organ toxicity occurred in only 2 patients (2.5%). Other causes of TRM included infection and GVHD. Median follow-up for the surviving patients was 1234 days (range, 780-1632 days). Current status includes 39 patients (49%) alive and in complete remission, 2 alive in relapse, and 39 dead. Relapse occurred in 15% of the good-risk group and 45% of the poor-risk group. The Kaplan-Meier estimates of 3-year disease-free and overall survival of the good-risk group were 77% and 85%, respectively, and of the poor-risk group were 34% and 36%, respectively. Low-dose (550 cGy), single-exposure TBI given at a high dose rate with cyclophosphamide resulted in consistent durable engraftment of HLA-matched sibling PBSC with a low risk of fatal organ toxicity and TRM.

    View details for Web of Science ID 000179405100005

    View details for PubMedID 12463480

  • Anemia, transfusion, and mortality. NEW ENGLAND JOURNAL OF MEDICINE GOODNOUGH, L. T., Bach, R. G. 2001; 345 (17): 1272-1274

    View details for Web of Science ID 000171773100010

    View details for PubMedID 11680450

  • Thrombopoietin therapy increases platelet yields in healthy platelet donors BLOOD Kuter, D. J., GOODNOUGH, L. T., Romo, J., DiPersio, J., Peterson, R., Tomita, D., Sheridan, W., McCullough, J. 2001; 98 (5): 1339-1345


    The recombinant thrombopoietins have been shown to be effective stimulators of platelet production in cancer patients. It was therefore of interest to determine if one of these, pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), could be used to increase platelet counts and consequently platelet yields from apheresis in healthy platelet donors. In a blinded, 2-cycle, crossover study, 59 platelet donors were randomized to receive a single subcutaneous injection of PEG-rHuMGDF (1 microg/kg or 3 microg/kg) or placebo and 15 days later undergo platelet apheresis. Donors treated with placebo had a median peak platelet count after PEG-rHuMGDF injection of 248 x 10(9)/L compared with 366 x 10(9)/L in donors treated with 1 microg/kg PEG-rHuMGDF and 602 x 10(9)/L in donors treated with 3 microg/kg PEG-rHuMGDF. The median maximum percentage that platelet counts increased from baseline was 10% in donors who received placebo compared with 70% in donors who received 1 microg/kg and 167% in donors who received 3 microg/kg PEG-rHuMGDF. There was a direct relationship between the platelet yield and the preapheresis platelet count: Placebo-treated donors provided 3.8 x 10(11) (range 1.3 x 10(11)-7.9 x 10(11)) platelets compared with 5.6 x 10(11) (range 2.6 x 10(11)-12.5 x 10(11)) or 11.0 x 10(11) (range 7.1 x 10(11)-18.3 x 10(11)) in donors treated with 1 microg/kg or 3 microg/kg PEG-rHuMGDF, respectively. Substandard collections (<3 x 10(11) platelets) were obtained from 26%, 4%, and 0% of the placebo, 1 microg/kg, and 3 microg/kg donors, respectively. No serious adverse events were reported; nor were there events that met the criteria for dose-limiting toxicity. Thrombopoietin therapy can increase platelet counts in healthy donors to provide a median 3-fold more apheresis platelets compared with untreated donors.

    View details for Web of Science ID 000170685000012

    View details for PubMedID 11520780

  • Prophylactic platelet transfusions from healthy apheresis platelet donors undergoing treatment with thrombopoietin BLOOD GOODNOUGH, L. T., Kuter, D. J., McCullough, J., Slichter, S. J., DiPersio, J., Romo, J., Peterson, R., Smith, K. J., Raife, T., Tomita, D., Armstrong, S. 2001; 98 (5): 1346-1351


    Many patients receiving dose-intensive chemotherapy acquire thrombocytopenia and need platelet transfusions. A study was conducted to determine whether platelets harvested from healthy donors treated with thrombopoietin could provide larger increases in platelet counts and thereby delay time to next platelet transfusion compared to routinely available platelets given to thrombocytopenic patients. Community platelet donors received either 1 or 3 microg/kg pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) or placebo and then donated platelets 10 to 15 days later. One hundred sixty-six of these platelet concentrates were then transfused to 120 patients with platelets counts 25 x 10(9)/L or lower. Pretransfusion platelet counts (11 x 10(9)/L) were similar for recipients of placebo-derived and PEG-rHuMGDF-derived platelets. Early after transfusion, the median platelet count increment was higher in patients receiving PEG-rHuMGDF-derived platelets: 19 (range, -12-66) x 10(9)/L, 41 (range, 5-133) x 10(9)/L, and 82 (range, -4-188) x 10(9)/L for placebo-, 1-microg/kg-, and 3-micro/kg-derived platelets, respectively. This difference was maintained 18 to 24 hours after transfusion. Transfusion-free intervals were 1.72, 2.64, and 3.80 days for the recipients of the placebo-, 1-microg/kg-, and 3-micro/kg-derived platelets, respectively. The rate of transfusion-related adverse events was not different in recipients of placebo-derived and PEG-rHuMGDF-derived platelets. Therefore, when transfused into patients with thrombocytopenia, platelets collected from healthy donors undergoing thrombopoietin therapy were safe and resulted in significantly greater platelet count increments and longer transfusion-free intervals than platelets obtained from donors treated with placebo.

    View details for Web of Science ID 000170685000013

    View details for PubMedID 11520781

  • Prestorage universal WBC reduction of RBC units does not affect the incidence of transfusion reactions TRANSFUSION Uhlmann, E. J., Isgriggs, E., Wallhermfechtel, M., Goodnough, L. T. 2001; 41 (8): 997-1000


    Febrile nonhemolytic transfusion reaction (FNHTR) has been identified as a pivotal reason for prestorage universal WBC reduction. A regional blood center implemented universal prestorage WBC reduction for RBCs on January 1, 2000. Whether prestorage universal WBC reduction of RBC units will affect FNHTR is not known.All reports of RBC transfusion reactions at Barnes-Jewish Hospital submitted for evaluation to the blood bank, before and after the implementation of WBC reduction of RBCs, were retrospectively evaluated.For the 36,303 allogeneic RBC transfusions administered in 1999, 85 reactions (0.23%) were reported. These reactions were classified as FNHTR in 43 cases, allergic in 13, delayed hemolytic in 19, and miscellaneous in 10. For the 31,543 non-WBC-reduced RBC transfusions performed in 1999, 78 reactions (0.25%) were reported. These reactions were classified as FNHTR in 39 cases, allergic in 13, delayed hemolytic in 19, and miscellaneous in 7. In the first half of 2000, 32 reactions (0.20%) were reported for 16,093 prestorage WBC-reduced RBC transfusions (p = 0.41). There were 13 FNHTRs and 10 allergic, 7 delayed hemolytic, and 2 miscellaneous reactions. The use of prestorage WBC-reduced RBCs did not significantly affect the rate of reactions classified as allergic (0.04% in 1999; 0.06% in 2000; p = 0.43) or as FNHTR (0.12% in 1999; 0.08% in 2000; p = 0.33). For all patients, universal WBC reduction in 2000 did not reduce the rate of FNHTR from the rate seen with selective bedside WBC reduction, the practice used in 1999 (0.12% in 1999; 0.08% in 2000; p = 0.36).No significant difference was found in the incidence of transfusion reactions in patients receiving prestorage WBC-reduced RBCs and non-WBC-reduced RBCs. In addition, no difference was found in transfusion reaction rates when periods of prestorage universal WBC reduction were compared to those of selective WBC reduction.

    View details for Web of Science ID 000170247500006

    View details for PubMedID 11493730

  • Transfusion medicine : support of patients undergoing cardiac surgery. American journal of cardiovascular drugs GOODNOUGH, L. T., Despotis, G. J. 2001; 1 (5): 337-351


    There is still no alternative that is as effective or as well tolerated as blood; nevertheless, the search for ways to conserve, and even eliminate blood transfusion, continues. Based on hemoglobin levels, practice guidelines for the use of perioperative transfusion of red blood cells in patients undergoing coronary artery bypass grafting have been formulated by the National Institutes of Health and the American Society of Anesthesiologists. However, it has been argued that more physiologic indicators of adequacy of oxygen delivery should be used to assess the need for blood transfusion. Methods used for conserving blood during surgery include autologous blood donation, acute normovolemic hemodilution and intra- and postoperative blood recovery and reinfusion. The guidelines for the use of autologous blood transfusion are controversial and it does not appear to be cost effective compared with allogeneic blood transfusion in patients undergoing cardiac surgery. Similarly, the cost effectiveness of intra- and postoperative blood recovery and reinfusion need further evaluation. Treatment with recombinant human erythropoietin (rhEPO) remains unapproved in the US for patients undergoing cardiac or vascular surgery, but it is a valuable adjunct in Jehovah's Witness patients, for whom blood is unacceptable. The characterization of darbepoetin alfa, a novel erythropoiesis stimulating protein with a 3-fold greater plasma elimination half-life compared with rhEPO, is an important advance in this field. Darbepoetin alfa appears to be effective in treating the anemia in patients with renal failure or cancer and trials in patients with surgical anemia are planned. Desmopressin has been used to effectively reduce intraoperative blood loss. Topical agents to prevent blood loss, such as fibrin glue and fibrin gel, and agents that alter platelet function, such as aspirin (acetylsalicylic acid) or dipyridamole, need further evaluation in patients undergoing cardiac surgery. Aprotinin has been shown to preserve hemostasis and reduce allogeneic blood exposure to a greater extent than the antifibrinolytic agents tranexamic acid and aminocaproic acid. Controlled clinical trials comparing the costs of these agents with clinical outcomes, along with tolerability profiles in patients at risk for substantial perioperative bleeding are needed.

    View details for PubMedID 14728016

  • Resolution of psoriasis after allogeneic bone marrow transplantation for chronic myelogenous leukemia: late complications of therapy BONE MARROW TRANSPLANTATION Adkins, D. R., Abidi, M. H., Brown, R. A., Khoury, H., GOODNOUGH, L. T., Vij, R., Westervelt, P., DiPersio, J. F. 2000; 26 (11): 1239-1241


    Treatment of autoimmune disease with bone marrow transplantation (BMT) is under investigation. A few reports of patients undergoing allogeneic BMT for malignant conditions observed the resolution of psoriasis after BMT, with minimal late morbidity. We describe a patient with chronic myelogenous leukemia (CML) whose psoriasis resolved completely after allogeneic BMT. However, the patient's course was complicated by extensive chronic graft-versus-host disease (GVHD), recurrent serious infections, poor performance status and quality of life, and severe disability. The patient died 887 days post transplant due to infectious complications. The potential benefits and risks of treatment of autoimmune diseases with allogeneic BMT are discussed.

    View details for Web of Science ID 000165851500018

    View details for PubMedID 11149740

  • The case against universal WBC reduction (and for the practice of evidence-based medicine) TRANSFUSION Goodnough, L. T. 2000; 40 (12): 1522-1527

    View details for Web of Science ID 000166224200017

    View details for PubMedID 11134574

  • Erythropoietin, iron, and erythropoiesis BLOOD Goodnough, L. T., Skikne, B., Brugnara, C. 2000; 96 (3): 823-833


    Recent knowledge gained regarding the relationship between erythropoietin, iron, and erythropoiesis in patients with blood loss anemia, with or without recombinant human erythropoietin therapy, has implications for patient management. Under conditions of significant blood loss, erythropoietin therapy, or both, iron-restricted erythropoiesis is evident, even in the presence of storage iron and iron oral supplementation. Intravenous iron therapy in renal dialysis patients undergoing erythropoietin therapy can produce hematologic responses with serum ferritin levels up to 400 microg/L, indicating that traditional biochemical markers of storage iron in patients with anemia caused by chronic disease are unhelpful in the assessment of iron status. Newer measurements of erythrocyte and reticulocyte indices using automated counters show promise in the evaluation of iron-restricted erythropoiesis. Assays for serum erythropoietin and the transferrin receptor are valuable tools for clinical research, but their roles in routine clinical practice remain undefined. The availability of safer intravenous iron preparations allows for carefully controlled studies of their value in patients undergoing erythropoietin therapy or experiencing blood loss, or both.

    View details for Web of Science ID 000088394000006

    View details for PubMedID 10910892

  • Effect of leukocyte compatibility on neutrophil increment after transfusion of granulocyte colony-stimulating factor-mobilized prophylactic granulocyte transfusions and on clinical outcomes after stem cell transplantation BLOOD Adkins, D. R., GOODNOUGH, L. T., Shenoy, S., Brown, R., Moellering, J., Khoury, H., Vij, R., DiPersio, J. 2000; 95 (11): 3605-3612


    The primary limitations of granulocyte transfusions include low component cell dose and leukocyte incompatibility. Component cell dose improved with granulocyte colony-stimulating factor (G-CSF) mobilization, and the transfusion of G-CSF-mobilized, human leukocyte antigen (HLA)-matched granulocyte components resulted in significant, sustained absolute neutrophil count (ANC) increments. However, the effect of leukocyte compatibility on outcomes with G-CSF-mobilized granulocyte transfusions is unclear. The objectives were to determine the effect of leukocyte compatibility on ANC increments and selected clinical outcomes after transfusion of prophylactic, G-CSF-mobilized granulocyte components into neutropenic recipients of autologous peripheral blood stem cell (PBSC) transplants. Beginning on transplant day 2, 23 evaluable recipients were scheduled to receive 4 alternate-day transfusions of granulocyte components apheresed from a single donor given G-CSF. G-CSF was also given to recipients after transplantation. Recipient ANC was determined before and sequentially after each granulocyte transfusion to determine the peak ANC increment. Leukocyte compatibility was determined at study entry only by a lymphocytotoxicity screening assay (s-LCA) against a panel of HLA-defined cells. Eight recipients had positive s-LCA. On days 2 and 4, the mean peak ANC increments after granulocyte transfusion were comparable between the cohorts with positive and negative s-LCA. However, the mean peak ANC increments on day 6 (246/microL vs 724/microL; P =.05) and day 8 (283/microL vs 1079/microL; P =.06) were lower in the cohort with positive s-LCA, in spite of the transfusion of comparable component cell doses. Adverse reactions occurred with only 5 of 87 (5.7%) granulocyte transfusions and were not associated with leukocyte compatibility test results. Platelet increments, determined 1 hour after granulocyte transfusion, were comparable between the cohorts. Although the 2 cohorts received PBSC components with similar CD34(+) cell doses, the cohort with a positive s-LCA had delayed neutrophil engraftment and a greater number of febrile days and required more days of intravenous antibiotics and platelet transfusions. Leukocyte incompatibility adversely affected ANC increments after the transfusion of G-CSF-mobilized granulocyte components and clinical outcomes after PBSC transplantation.

    View details for Web of Science ID 000087351600047

    View details for PubMedID 10828051

  • Blood conservation in patients undergoing non-cardiac surgery. Current opinion in anaesthesiology Goodnough, L. T., Monk, T. G. 2000; 13 (3): 365-370


    Concerns about the safety, inventory, and cost of allogeneic blood have led to a renewed interest in blood conservation. Autologous blood collection techniques, including preoperative autologous donation, acute normovolemic hemodilution, and perioperative blood recovery are routinely used as alternatives to allogeneic transfusion. In the future, these techniques may be combined with pharmacological strategies, such as presurgical erythropoietin therapy or red cell substitutes, to reduce further the need for allogeneic blood.

    View details for PubMedID 17016330

  • Adverse side-effects associated with G-CSF in patients with chronic myeloid leukemia undergoing allogeneic peripheral blood stem cell transplantation BONE MARROW TRANSPLANTATION Khoury, H., Adkins, D., Brown, R., Vij, R., Westervelt, P., Trinkaus, K., GOODNOUGH, L. T., DiPersio, J. F. 2000; 25 (11): 1197-1201


    Administration of the myeloid growth factor G-CSF after allogeneic hematopoietic stem cell transplantation is usually well tolerated, and associated with rapid hematopoietic engraftment. We report a high incidence (50%) of side-effects associated with post-transplant G-CSF in patients with chronic phase chronic myeloid leukemia undergoing allogeneic HLA-identical sibling peripheral blood stem cell transplantation. One or more of the following signs and symptoms were observed shortly after the subcutaneous injection of G-CSF: dyspnea, chest pain, nausea, hypoxemia, diaphoresis, anaphylaxis, syncope and flushing. These reactions led to discontinuation of G-CSF in the majority of patients. Predictive factors could not be identified, and the underlying mechanism leading to these reactions is unknown.

    View details for Web of Science ID 000087483600012

    View details for PubMedID 10849533

  • Clinical consequences of alterations in platelet transfusion dose: a prospective, randomized, double-blind trial TRANSFUSION Brecher, M. E., GOODNOUGH, L. T. 2000; 40 (3): 383-384

    View details for Web of Science ID 000086036200024

    View details for PubMedID 10738044

  • Innovations in allogeneic stem-cell transplantation SEMINARS IN HEMATOLOGY DiPersio, J. F., Khoury, H., Haug, J., Vij, R., Adkins, D. R., GOODNOUGH, L. T., Brown, R. A. 2000; 37 (1): 33-41


    Allogeneic bone marrow transplantation (BMT) is associated with prolonged periods of neutropenia and thrombocytopenia, which can lead to severe infections and bleeding complications. Transplantation-related side effects might be ameliorated by use of cytokine-mobilized peripheral blood progenitor cells (PBPC) Instead of bone marrow. We have studied PBPC mobilization and transplantation in more than 150 patients with high-risk hematologic malignancies. Normal donors can be sufficiently mobilized with granulocyte colony-stimulating factor (G-CSF), with 91% of G-CSF-stimulated normal donors producing more than 2 x 10(6) CD34+ cells/kg by a single apheresis. The combination of G-CSF plus granulocyte-macrophage colony-stimulating factor (GM-CSF) was more effective than mobilization with G-CSF alone. A clear relationship was seen between numbers of resting CD34+ cells premobilization and numbers of PBPC collected by apheresis, indicating that resting CD34+ cells might be used to predict mobilization results and identify donors who could benefit from more effective mobilization regimens. Transplantation of G-CSF-mobilized PBPC was associated with a more rapid engraftment than that observed for BMT. While engraftment was safe and acute graft-versus-host disease (aGvHD) rates were not increased over BMT, chronic GvHD rates were higher after PBPC transplantation. An additional PBPC infusion on day +3 resulted in a further shortening of neutropenia and thrombocytopenia. Incorporation of these innovative approaches with "minimal" conditioning regimens has resulted in near-complete elimination of fever, neutropenia, thrombocytopenia, and the need for antibiotics and RBC and platelet transfusions after allogeneic transplantation.

    View details for Web of Science ID 000085625300006

    View details for PubMedID 10718157

  • What is a transfusion medicine specialist? TRANSFUSION GOODNOUGH, L. T. 1999; 39 (9): 1031-1033

    View details for Web of Science ID 000082570200019

    View details for PubMedID 10533832

  • A prospective randomized comparison of three blood conservation strategies for radical prostatectomy ANESTHESIOLOGY Monk, T. G., GOODNOUGH, L. T., Brecher, M. E., Colberg, J. W., Andriole, G. L., Catalona, W. J. 1999; 91 (1): 24-33


    Preoperative autologous blood donation is a standard of care for elective surgical procedures requiring transfusion. The authors evaluated the efficacy of alternative blood-conservation strategies including preoperative recombinant human erythropoietin (rHuEPO) therapy and acute normovolemic hemodilution (ANH) in radical retropubic prostatectomy patients.Seventy-nine patients were prospectively randomized to preoperative autologous donation (3 U autologous blood); rHuEPO plus ANH (preoperative subcutaneous administration of 600 U/kg rHuEPO at 21 and 14 days before surgery and 300 U/kg on day of surgery followed by ANH in the operating room); or ANH (blinded, placebo injections per the rHuEPO regimen listed previously). Transfusion outcomes, perioperative hematocrit levels, postoperative outcomes, and blood-conservation costs were compared among the three groups.Baseline hematocrit levels were similar in all groups (43%+/-2%). On the day of surgery hematocrit decreased to 34% +/-4% in the preoperative autologous donation group (P < 0.001), increased to 47%+/-2% in the rHuEPO plus ANH group (P < 0.001), and remained unchanged at 43%+/-2% in the ANH group. Allogeneic blood exposure was similar in all groups. The rHuEPO plus ANH group had significantly higher hematocrit levels compared with the other groups throughout the hospitalization (P < 0.001). Average transfusion costs were significantly lower for ANH ($194+/-$192) compared with preoperative autologous donation ($690+/-$128; P < 0.001) or rHuEPO plus ANH ($1,393+/-$204, P < 0.001).All three blood-conservation strategies resulted in similar allogeneic blood exposure rates, but ANH was the least costly technique. Preoperative rHuEPO plus ANH prevented postoperative anemia but resulted in the highest transfusion costs.

    View details for Web of Science ID 000081188400007

    View details for PubMedID 10422925

  • Optimal management of bleeding and transfusion in patients undergoing cardiac surgery. Seminars in thoracic and cardiovascular surgery Despotis, G. J., Skubas, N. J., GOODNOUGH, L. T. 1999; 11 (2): 84-104


    Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) are at increased risk for excessive perioperative blood loss requiring transfusion of blood products. Point-of-care evaluation of platelets, coagulation factors, and fibrinogen can enable physicians to rapidly assess bleeding abnormalities, facilitate the optimal administration of pharmacological and transfusion-based therapy, and also identify patients with surgical bleeding. The ability to reduce the unnecessary use of blood products in this setting has important implications for emerging issues in blood inventory and blood costs. The ability to decrease surgical time, along with exploration rates, has important consequences for health care costs in an increasingly managed health care environment.

    View details for PubMedID 10378853

  • The value of oxygen-carrying solutions in the operative setting, as determined by mathematical modeling TRANSFUSION Brecher, M. E., GOODNOUGH, L. T., Monk, T. 1999; 39 (4): 396-402


    The use of oxygen carriers (red cell [RBC] substitutes) in acute trauma and in surgery, with or without the use of acute normovolemic hemodilution (ANH), is being investigated. Mathematical modeling was used to assess the impact of RBC substitutes, with or without ANH, in the elective surgical setting.Mathematical equations and computer models were developed on the basis of previously described mathematical principles, for better understanding of the potential efficacy of RBC substitutes for blood needs with or without ANH. Savings were calculated for a patient with a blood volume of 5000 mL and an initial hematocrit (Hct) of 45 or 30 percent.Substantial increases in the tolerable blood losses (or reduced allogeneic RBC needs) were most evident when the use of an RBC substitute to achieve severe ANH to a Hct that the patient might not otherwise have been able to tolerate was combined with the use of RBC substitutes as replacement for the surgical blood subsequently lost. However, the benefit was greatly dependent on the patient's initial Hct. For example, for a patient with a blood volume of 5000 mL and an initial Hct of 45 percent, a blood loss of approximately 2500 mL resulted in a final Hct of 28 percent without the use of an RBC substitute or ANH. In contrast, with the combined use of staged ANH with an RBC substitute and the RBC substitute for lost surgical blood, a blood loss of up to 14.5 L could be tolerated. However, in an anemic patient (blood volume 5000 mL, initial Hct 30%), a Hct of 28 percent cannot be sustained without the use of allogeneic RBCs for any of the described strategies, even when blood losses were as low as 1 L.The use of RBC substitutes has the potential to result in a substantial reduction in allogeneic RBC exposure. This benefit is essentially limited to the nonanemic patient when the use of an RBC substitute is combined with severe ANH and there is concomitant large perioperative blood loss. Anemic patients can be expected to have only limited benefit, because of an inability to sequester an adequate volume of autologous RBCs via ANH.

    View details for Web of Science ID 000079760400011

    View details for PubMedID 10220267

  • Where does preoperative erythropoietin therapy count? A mathematical perspective TRANSFUSION Brecher, M. E., GOODNOUGH, L. T., Monk, T. 1999; 39 (4): 392-395


    The administration of erythropoietin (EPO) can be used to increase a patient's hematocrit (Hct) in the preoperative period and thus possibly preclude the need for allogeneic red cells. However, the exact effect on the postoperative Hct of a given rise in Hct in the preoperative period (and on the avoidance of allogeneic blood) has not been thoroughly evaluated.Equations were developed on the basis of previously described relationships that allowed the assessment of the impact of a given preoperative Hct increase on the postoperative Hct under a variety of clinical situations.Equations were derived that related the change in preoperative Hct after the administration of EPO to the final Hct after a given blood loss. In a typical example (blood volume = 5000 mL, pre-EPO Hct of 40%, post-EPO Hct of 45% after blood losses of 1000, 2000, 3000, 4000, 5000, and 6000 mL), an additional 205, 168, 137, 112, 92, and 75 mL of red cells, respectively, would be present postoperatively over the volume in the same patient who did not receive EPO. For a smaller patient, such as a child (blood volume, 2500 mL), an additional 17 mL (5000-mL blood loss) to 83 mL (1000-mL blood loss) of red cells would be present postoperatively. Hemodilution and EPO act synergistically to yield additional postoperative red cell volume.The use of preoperative EPO with a preoperative increase in Hct results in an increased postoperative Hct after a surgical blood loss. Such a postoperative increase is a function of the volume of blood lost and the patient's blood volume but is independent of the patient's initial Hct. The final postoperative red cell volume increase associated with a preoperative increase in Hct of 1 to 5 percent is limited, however (generally equivalent to a fraction of 1 unit of allogeneic blood). Much of the increase in the patient's Hct vanishes at higher blood losses, and this therapy is most effective with blood loss of <4000 mL. EPO therapy alone may be most effectively used in patients with mild anemia who are undergoing routine surgical procedures that commonly require blood transfusion.

    View details for Web of Science ID 000079760400010

    View details for PubMedID 10220266

  • Long-term follow-up of high-risk allogeneic peripheral-blood stem-cell transplant recipients: Graft-versus-host disease and transplant-related mortality JOURNAL OF CLINICAL ONCOLOGY Brown, R. A., Adkins, D., Khoury, H., Vij, R., GOODNOUGH, L. T., Shenoy, S., DiPersio, J. F. 1999; 17 (3): 806-812


    To determine the risks of graft-versus-host disease (GVHD) and transplant-related mortality after allogeneic peripheral-blood stem-cell (PBSC) transplantation.Between December 1994 and July 1996, 50 consecutive patients with high-risk hematologic malignancies in first remission or relapse received high-dose therapy followed by transplantation of granulocyte colony-stimulating factor-mobilized, allogeneic PBSCs collected from HLA-identical siblings. GVHD prophylaxis included cyclosporine and corticosteroids.As of April 1, 1998, 18 patients (36%+/-13%) survived with a median follow-up period of 767 days (range, 602 to 1,127 days). The actuarial probability of grades 2-4 acute GVHD was 0.37+/-0.14 (95% confidence interval). Of 36 assessable patients, 26 (72%+/-15%) developed chronic GVHD. The actuarial probability of chronic GVHD 2 years after transplantation was 0.87+/-0.15. Of 14 progression-free survivors, 11 (79%+/-22%) have active, chronic GVHD. All 11 patients require ongoing immunosuppression, and nearly two thirds have extensive disease. Thirteen patients died as a result of transplant-related mortality (26%+/-12%), six (12%) before and seven (14%) after day +100.We observed a high risk of chronic GVHD after allogeneic PBSC transplantation, which compromised the performance status of most long-term survivors and resulted in a relatively high risk of late transplant-related mortality. Approximately 75% of transplant-related deaths were associated with GVHD; thus, reduction in transplant-related mortality after allogeneic PBSC transplantation will require more effective strategies for the prophylaxis and/or treatment of GVHD.

    View details for Web of Science ID 000078972800011

    View details for PubMedID 10071270

  • Medical progress - Transfusion medicine - Second of two parts - Blood conservation NEW ENGLAND JOURNAL OF MEDICINE GOODNOUGH, L. T., Brecher, M. E., Kanter, M. H., AUBUCHON, J. P. 1999; 340 (7): 525-533
  • Medical progress - Transfusion medicine (First of two parts) - Blood transfusion NEW ENGLAND JOURNAL OF MEDICINE GOODNOUGH, L. T., Brecher, M. E., Kanter, M. H., AUBUCHON, J. P. 1999; 340 (6): 438-447
  • A randomized trial of acute normovolemic hemodilution compared to preoperative autologous blood donation in total knee arthroplasty VOX SANGUINIS Goodnough, L. T., Monk, T. G., Despotis, G. J., Merkel, K. 1999; 77 (1): 11-16


    The value of acute normovolemic hemodilution (ANH) compared to preoperative autologous blood donation (PAD) in elective surgery is controversial. We therefore conducted a prospective, randomized study to compare these techniques in patients undergoing total knee arthroplasty. ANH patients underwent up to 4 units phlebotomy or to a target hematocrit level of 28% after induction of anesthesia. PAD patients were asked to donate 1 (unilateral) or 2 (bilateral, revisions) units before admission. Mean baseline hematocrit levels were not different between ANH and PAD patients (40.6+/-4.1 vs. 38. 4+/-3.4, p = 0.09). Eight (73%) of 11 patients undergoing bilateral revision procedures received a total of 22 allogeneic blood units, whereas only 3 (14%) of 21 patients undergoing primary, unilateral procedures received a total of 3 allogeneic units (p = 0.002). We found no differences in allogeneic blood transfusions between ANH and PAD cohorts for all (n = 32) patients (1.0+/-1.2 vs. 0.6+/-1.4, p = 0.45), for unilateral knee (n = 21) replacement (0.25+/-0.46 vs. 0.08+/-0.28, p = 0.29), or for bilateral/revision (n = 11) procedures (1.9+/-1.3 vs. 2.5+/-1.9, p = 0.53). We conclude that each technique is equally effective in reducing allogeneic blood exposure. Patients undergoing revision or bilateral knee arthroplasties require adjunctive therapy to autologous blood procurement to further reduce allogeneic blood exposure.

    View details for Web of Science ID 000082415000003

    View details for PubMedID 10474085

  • Economic impact of donor platelet count and platelet yield in apheresis products: Relevance for emerging issues in platelet transfusion therapy VOX SANGUINIS Goodnough, L. T., Ali, S., Despotis, G., Dynis, M., DiPersio, J. F. 1999; 76 (1): 43-49


    We analyzed donor platelet counts and platelet product yields in 708 consecutive platelet aphereses in our program in order to define the importance of this relationship for emerging issues in platelet transfusion therapy.Aphereses performed on the Spectra 3.6 (COBE, Lakewood. Colo.) the CS-3000 Plus (Fenwall-Baxter, Deerfield, Ill.) were analyzed.Mean platelet count was 237+/-49x10(3)/mm3 (mean +/- SD), and mean yield was 4.24+/-1. 09x10(11) platelets. Eigthy-five (12%) procedures generated less that 3x10(11) platelets. Only thirty-eight (5.4%) procedures yielded >/=6x10(11) platelets, so that 'split products' could be obtained. Platelet yields were primarily related to the biologic contribution (baseline platelet count) of the donor. Procedure parameters selected for harvest, and the efficiency of the device also had a significant, but less important role in determining the final platelet yield. An increase in mean donor platelet count achieved with Mpl ligand therapy from 240,000 to 320,000/mm3 would reduce the cost from USD 378 to 267 for each apheresis product, since the fraction of split products would exceed 50% of apheresis procedures.Increasing the donor platelet count would have a significant economic impact on platelet apheresis programs, as well as important clinical consequences for the role of platelet apheresis products in future transfusion strategies.

    View details for Web of Science ID 000078542900006

    View details for PubMedID 9933853

  • Prevalence of HLA sensitization in female apheresis donors TRANSFUSION Densmore, T. L., GOODNOUGH, L. T., Ali, S., Dynis, M., Chaplin, H. 1999; 39 (1): 103-106


    Transfusion-related acute lung injury (TRALI) is a serious complication of plasma-containing blood components. Studies have implicated HLA antibodies along with biologically active lipids in stored blood in the pathogenesis of TRALI. It has been proposed that the exclusion of HLA-untested, multiparous donors of plasma-rich components, including plasma and single-donor apheresis platelets, would substantially reduce the risk of TRALI.To investigate the feasibility of such an exclusion, 332 female plateletpheresis donors with a record of over 9000 donations, none of which were associated with TRALI, were studied.Seventeen percent of female donors demonstrated HLA sensitization. Parity and HLA sensitization were significantly correlated (p<0.0001), with sensitized donors having an average of 2.9 (+/- 0.6 95% CI) prior pregnancies and unsensitized donors having an average of 1.8 (+/- 0.2 95% CI) prior pregnancies. The percentage of HLA-sensitized women with 0, 1 to 2, and > or = 3 pregnancies was 7.8, 14.6, and 26.3, respectively.These findings confirm the hypothesis that multiparous women (> or = 3 pregnancies) represent an increased potential risk for TRALI. However, the exclusion of multiparous plateletpheresis donors would eliminate one-third of our female donor pool. Screening such donors for HLA sensitization may represent the optimal approach for identifying donors at risk for causing TRALI, but this still would result in the deferral of 8 percent of female plateletpheresis donors. At present, prospective screening to identify donors at risk for causing TRALI is not justified.

    View details for Web of Science ID 000078050300015

    View details for PubMedID 9920173

  • Controversies in autologous blood procurement BRITISH JOURNAL OF ANAESTHESIA GOODNOUGH, L. T. 1998; 81: 67-72

    View details for Web of Science ID 000077599600014

    View details for PubMedID 10318992

  • Oxygen carriers as blood substitutes - Past, present, and future CLINICAL ORTHOPAEDICS AND RELATED RESEARCH GOODNOUGH, L. T., Scott, M. G., Monk, T. G. 1998: 89-100


    Prospects for safe and effective blood substitutes are promising, based on clinical trial results of soluble hemoglobin solutions and emulsion of perfluorocarbins. Advantages of blood substitutes include sterilization of viral and bacterial contaminants, room temperature storage, a long shelf life, and absence of ABO and other red cell antigens. Projected arenas for their use include not only military applications but also trauma medicine and elective surgical settings, coupled with acute normovolemic hemodilution. Applications of perfluorocarbons are limited by the need for 100% FIO2. A significant challenge facing development of hemoglobin solutions is their effect on vascular tone through smooth muscle constriction. Development of second or third generation hemoglobin solutions may be necessary so that hemoglobin solutions more closely mimic cellular hemoglobin's nitric oxide binding properties. Optimizing O2 delivery to ischemic tissues and organs may lead to regulatory approval of these agents in this setting before their approval as blood substitutes.

    View details for Web of Science ID 000077850700014

    View details for PubMedID 9917705

  • Erythropoietin therapy in the perioperative setting CLINICAL ORTHOPAEDICS AND RELATED RESEARCH GOODNOUGH, L. T., Monk, T. G. 1998: 82-88


    Recombinant human erythropoietin has been approved for use in patients undergoing autologous donation in Japan, Europe, and Canada since 1993, 1994, and 1996, respectively, and for perisurgical adjuvant therapy without autologous donation in Canada and the United States since 1996. Early clinical trials of erythropoietin therapy in the setting of autologous donation have provided important information regarding clinical safety, erythropoietin dose, and erythropoietic response. Later trials of perisurgical erythropoietin therapy without autologous donation provided data on efficacy (reduced allogeneic blood exposure) that led to approval of erythropoietin in patients undergoing surgery. However, the erythropoietin doses (300 U/kg subcutaneous x14 days) used in these trials, and their subsequent inclusion in labeling for the use of this product, are costly and tedious to administer. A recent study reported that a weekly regimen of erythropoietin (600 U/kg) for 4 weeks is less costly but just as effective at reducing allogeneic blood exposure in elective orthopaedic surgery. The most cost effective regimen that has been shown to minimize allogeneic exposure is preoperative erythropoietin therapy (600 U/kg subcutaneous weekly x2 and 300 U/kg subcutaneous on day of surgery) coupled with acute normovolemic hemodilution in patients undergoing radical retropubic prostatectomy. A similar regimen of erythropoietin therapy in patients undergoing coronary artery bypass grafting (2500 U/kg subcutaneous in divided doses for 2 weeks preoperatively) coupled with hemodilution also was effective. Low dose erythropoietin therapy coupled with acute normovolemic hemodilution ultimately may be shown to be cost equivalent to the predonation of three autologous blood units before elective surgery.

    View details for Web of Science ID 000077850700013

    View details for PubMedID 9917704

  • Acute normovolemic hemodilution CLINICAL ORTHOPAEDICS AND RELATED RESEARCH Monk, T. G., GOODNOUGH, L. T. 1998: 74-81


    Acute normovolemic hemodilution was described to be useful as a blood conservation strategy more than 25 years ago, yet seldom is practiced today. The benefit of acute normovolemic hemodilution is perceived to be modest and the technique is not taught in anesthesia or surgery training programs. Acute normovolemic hemodilution is an autologous blood procurement strategy that is superior to the predeposit of autologous blood for several reasons: Acute normovolemic hemodilution is less costly, with an average cost of $25 per unit compared with $175 per unit predonated; and acute normovolemic hemodilution units are reinfused to patients before the patient leaves the operating room, so that the units need not be tested and there is no possibility of administrative error. Emerging clinical studies now show that acute normovolemic hemodilution is equivalent to predonated autologous blood in reducing allogeneic blood exposure in patients undergoing elective surgery.

    View details for Web of Science ID 000077850700012

    View details for PubMedID 9917703

  • Perioperative myocardial ischemic episodes are related to hematocrit level in patients undergoing radical prostatectomy TRANSFUSION Hogue, C. W., GOODNOUGH, L. T., Monk, T. G. 1998; 38 (10): 924-931


    The anemia associated with perioperative blood conservation has raised concerns regarding the safety of these strategies in patients with ischemic cardiovascular disease. Therefore the relationship between hematocrit level and myocardial ischemic episodes in a group of elderly patients undergoing elective noncardiac surgery was studied.One hundred ninety patients undergoing radical prostatectomy were randomly assigned to one of three blood conservation groups: preoperative autologous blood donation, acute normovolemic hemodilution, and preoperative erythropoietin therapy with acute normovolemic hemodilution. Patients underwent ambulatory electrocardiography monitoring to evaluate for myocardial ischemia at randomization (baseline), 7 days preoperatively, throughout surgery, and for 24 hours after surgery.Myocardial ischemic episodes occurred in 61 (34%) of 181 evaluable patients. Patients with hematocrit levels < 28 percent immediately after surgery were significantly (p = 0.05) more likely to have intraoperative and postoperative ECG ischemic episodes. Intraoperative ischemia and tachycardia correlated (r = 0.21, p = 0.008) with hematocrit levels. Hematocrit levels after surgery were associated with postoperative ischemia (r = 0.14, p = 0.03) and duration of myocardial ischemic episodes (r = 0.14, p = 0.04). After adjusting for other risk factors, intraoperative tachycardia episodes, hematocrit level < 28 percent immediately after surgery, and risk factors for coronary artery disease were independently associated with the likelihood of intraoperative ischemia (r = 0.36, p = 0.002, area under receiver operating characteristic curve = 0.73). Similarly, tachycardia episodes and hematocrit levels < 28 percent immediately after surgery were independently associated with ischemic episodes during the first postoperative day (r = 0.30, p = 0.004, area under receiver operating characteristic curve = 0.71).A hematocrit level < 28 percent is independently associated with risk for myocardial ischemia during and after noncardiac surgery. Avoidance of cardiac complications may require higher transfusion thresholds, closer attention to tachycardia, or better monitoring for ischemia.

    View details for Web of Science ID 000076158100006

    View details for PubMedID 9767742

  • Guidelines for the treatment of preoperative anaemia with epoetin BIODRUGS Goodnough, L. T. 1998; 10 (3): 183-191


    Recombinant human erythropoietin (epoetin) has been approved for use in patients undergoing autologous blood donation (ABD) in Japan, the European Union and Canada since 1993, 1994 and 1996 respectively, and for perisurgical adjuvant therapy without ABD in Canada and the US since 1996. Early clinical trials of epoetin therapy in the setting of ABD have provided important information with respect to clinical safety, dose and erythropoietic response. Later trials of perisurgical epoetin therapy without ABD provided data on efficacy (i.e. reduced allogeneic blood exposure) that led to approval of epoetin in this setting. However, the epoetin doses (300 U/kg subcutaneously x 14 days) used in these trials, and their subsequent inclusion in labelling for the use of this product, are costly to administer. A recent study has indicated that weekly administration of epoetin 600 U/kg over 4 weeks is just as effective but less costly than a daily regimen over 2 weeks. The most cost-effective regimen that has been shown to minimise allogeneic exposure is preoperative epoetin therapy with 600 U/kg/ week x 2 plus 300 U/kg on the day of surgery, coupled with acute normovolaemic haemodilution in patients undergoing radical retropubic prostatectomy. A similar regimen of epoetin therapy in patients undergoing coronary artery bypass grafting (2500 U/kg in divided doses over 2 weeks preoperatively) coupled with 'blood pooling', has also been described. 'Low dose' epoetin therapy coupled with acute normovolaemic haemodilution is cost-equivalent to the predonation of 3 autologous blood units, and may replace this strategy as a standard of care in the elective surgical setting.

    View details for Web of Science ID 000076014300002

    View details for PubMedID 18020594

  • The Collaborative Hospital Transfusion Study: variations in use of autologous blood account for hospital differences in red cell use during primary hip and knee surgery TRANSFUSION Churchill, W. H., McGurk, S., Chapman, R. H., Wallace, E. L., Bertholf, M. F., GOODNOUGH, L. T., Kao, K. J., Olson, J. D., Woodson, R. D., Surgenor, D. M. 1998; 38 (6): 530-539


    Red cell use in patients undergoing Diagnosis Related Group (DRG) 209 procedures (major joint and limb reconstruction procedures of the lower extremities) has been shown to have large, unexplained interhospital variations.Abstracted records of 2590 consecutive DRG 209 patients at five university hospitals from January 1992 to December 1993 were stratified by procedure and preoperative blood deposit status. Patient characteristics and transfusion and in-hospital outcomes were compared across hospitals.Blood use among patients who did not preoperatively deposit blood was similar across hospitals. Significant differences were found across hospitals for total hip replacement patients in the percentage of patients preoperatively depositing blood (59-80%), percentage of patients receiving transfusion(s) (51 to > 99%), the mean number of units collected per patient (1.6-2.9), and the mean number of unused autologous units per 100 patients (1-185). No significant differences were found in the percentage of those who deposited blood and then required allogeneic units. There was little variability in length of hospital stay or in last hematocrits. Findings were similar for total knee replacement patients.Interhospital variations in red cell use for primary total hip and knee reconstruction are primarily due to hospital-specific differences in autologous blood collection and transfusion.

    View details for Web of Science ID 000074561900003

    View details for PubMedID 9661686

  • Compensatory erythropoiesis during routine autologous blood donation TRANSFUSION GOODNOUGH, L. T., Mercuriali, F. 1998; 38 (6): 613-614

    View details for Web of Science ID 000074561900015

    View details for PubMedID 9661698

  • Future directions in utilization review: The role of transfusion algorithms TRANSFUSION SCIENCE Goodnough, L. T., Despotis, G. J. 1998; 19 (1): 97-105


    Transfusion practice guidelines and retrospective utilization review have been ineffective in curtailing the inappropriate use of blood and blood products, particularly in cardiac surgical patients. Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) are at increased risk for excessive perioperative blood loss requiring transfusion of blood products. Recent evaluations have focused on the use of point-of-care coagulation assays for patient-specific therapy. Blood component administration in patients with excessive post-CPB bleeding is generally empiric, in part related to the times required to perform of laboratory-based tests. Methods are now available for rapid, on-site assessment of coagulation assays to allow appropriate, targeted therapy for acquired hemostatic abnormalities. Recent studies indicate that a rapid evaluation of thrombocytopenia and coagulation factor deficiencies, coupled with transfusion algorithms, can facilitate the optimal administration of transfusion-based therapy in patients who exhibit excessive bleeding after CPB. The use of point-of-care assays and transfusion algorithms may provide an effective concurrent method of utilization review of blood products in the surgical setting.

    View details for Web of Science ID 000074350400016

    View details for PubMedID 10182188

  • The specific hospital significantly affects red cell and component transfusion practice in coronary artery bypass graft surgery: a study of five hospitals TRANSFUSION Surgenor, D. M., Churchill, W. H., Wallace, E. L., Rizzo, R. J., McGurk, S., GOODNOUGH, L. T., Kao, K. J., KOERNER, T. A., Olson, J. D., Woodson, R. D. 1998; 38 (2): 122-134


    Interhospital differences in blood transfusion practice during coronary artery bypass graft (CABG) surgery have been noted, but the underlying issues have not been identified.Records of 3217 consecutive CABG cases in five university teaching hospitals in 1992 and 1993 were stratified by hospital, type of revascularization conduit, patients' sex, and other factors. Statistical methods were used to compare patient characteristics, transfusion outcomes, and hospital outcomes.Forward two-step logistic regression using patient likelihood of red cell transfusion factors in the first step and the specific hospital in the second step revealed a significant effect of hospital on the delta odds ratios for red cell transfusion. This finding was confirmed by analyses of a highly stratified subset of cases, males in diagnosis-related group 107 (primary cases of coronary bypass without coronary catheterization) who underwent revascularization with venous and internal mammary artery grafts, revealing variations among hospitals from 109 to 457 units of red cells transfused per hundred cases. Corresponding variations in transfusions of all blood components were from 324 to 1019 units by hospital. Variation in red cell transfusion practice among surgeons in the same hospital was not responsible for these interhospital differences.The effect of the specific hospital on transfusion practice is attributed to institutional differences that, through reasons of training or hierarchy, become ingrained in hospitals.

    View details for Web of Science ID 000072612800002

    View details for PubMedID 9531943

  • Erythropoiesis in patients stimulated with erythropoietin: The relevance of storage iron VOX SANGUINIS GOODNOUGH, L. T., Marcus, R. E. 1998; 75 (2): 128-133


    The clinical importance of iron-restricted erythropoiesis in erythropoietin (EPO)-stimulated patients is controversial.We therefore reviewed 70 patients randomized into clinical trials of aggressive autologous donation and oral iron supplementation, with or without recombinant human EPO therapy.Nineteen (27%) iron-depleted patients produced 5.4+/-2.8 ml RBC/kg compared to 4.8+/-2.3 ml RBC/kg (nonsignificant) in iron-replete patients due to endogenous EPO (placebo group) stimulation. EPO-treated iron-depleted patients produced 20% less RBC than iron-replete patients (8.23+/-3.3 vs. 10. 2+/-4.0, p = 0.066). RBC volume expansion correlated with initial storage iron only in iron-replete patients who received EPO therapy.Initial storage iron status is a marginally important limitation to EPO-mediated erythropoiesis in the setting of oral iron supplementation. Strategies to maintain plasma transferrin saturation with intravenous iron therapy may be desirable to improve the erythropoietic response to EPO in this setting.

    View details for Web of Science ID 000076711500006

    View details for PubMedID 9784666

  • Treatment of resistant mantle cell lymphoma with allogeneic bone marrow transplantation BONE MARROW TRANSPLANTATION Adkins, D., Brown, R., GOODNOUGH, L. T., Khoury, H., Popovic, W., DiPersio, J. 1998; 21 (1): 97-99


    Conventional approaches to the treatment of recurrent mantle cell lymphoma (MCL) yield unsatisfactory results. We describe a patient with recurrent MCL in leukemic phase refractory to chemotherapy who was successfully treated with allogeneic bone marrow transplantation. At last follow-up 1 year post-transplant, the patient was in complete remission and had limited chronic graft-versus-host disease.

    View details for Web of Science ID 000072225200017

    View details for PubMedID 9486503

  • Apheresis platelets: Emerging issues related to donor platelet count, apheresis platelet yield, and platelet transfusion dose JOURNAL OF CLINICAL APHERESIS Goodnough, L. T., Kuter, D., McCullough, J., Brecher, M. E. 1998; 13 (3): 114-119


    Emerging issues in stimulating apheresis platelet donors with platelet growth factors, the relative costs of apheresis and random donor platelet concentrates, optimal platelet transfusion dose, and leucoreduction of platelet products have caused renewed debate regarding apheresis products vs. random, pooled concentrates. The future role of apheresis products in platelet transfusion therapy will in large part be determined by costs, which are increasingly recognized to be influenced by donor platelet count, apheresis yield, and platelet transfusion dose.

    View details for Web of Science ID 000076758800004

    View details for PubMedID 9828021

  • Erythropoietin therapy in patients undergoing cardiac operations ANNALS OF THORACIC SURGERY Goodnough, L. T., Despotis, G. J., Parvin, C. A. 1997; 64 (6): 1579-1580

    View details for Web of Science ID 000071469400001

    View details for PubMedID 9436537

  • Factors that influence the collection and engraftment of allogeneic peripheral-blood stem cells in patients with hematologic malignancies JOURNAL OF CLINICAL ONCOLOGY Brown, R. A., Adkins, D., GOODNOUGH, L. T., Haug, J. S., Todd, G., Wehde, M., Hendricks, D., EHLENBECK, C., LAUB, L., DiPersio, J. 1997; 15 (9): 3067-3074


    To determine the number of CD34+ cells associated with a high probability of rapid engraftment after allogeneic peripheral-blood stem-cell (PBSC) transplant, and to examine the relationship between certain donor characteristics and the effectiveness of PBSC mobilization.Between December 1994 and July 1996, we treated 47 patients who had resistant hematologic neoplasms with myeloablative therapy followed by transplantation of allogeneic PBSC collected from histocompatible siblings after mobilization with granulocyte colony-stimulating factor (G-CSF). Expression of CD34 was determined by flow cytometry.Engraftment was rapid and similar to that observed following autologous PBSC transplant, with an absolute neutrophil count (ANC) greater than 500/microL and platelet count greater than 20,000/microL on median days +9 and +11, respectively. The pace of hematologic recovery correlated with the number of hematopoietic progenitors transplanted, so that patients who received greater than 5 x 10(6) CD34+ cells/kg recipient weight had a 95% likelihood of neutrophil and platelet recovery by day +15. Baseline (precytokine) CD34+ cells per milliliter of donor peripheral blood and total G-CSF dose (donor weight x 10 micrograms/kg) correlated with the number of CD34+ cells collected (R2 = .24 and P = .0009, and R2 = .24 and P < .0001, respectively). Donor age and sex did not effect mobilization.Following allogeneic PBSC transplant, patients who received greater than 5 x 10(6) CD34+ cells/ kg recipient weight had a high probability of rapid engraftment. Donors with low baseline levels of circulating progenitors (< 2,000 CD34+ cells/mL blood) and those who received lower total doses of G-CSF were less likely to be effectively mobilized. For donors with low baseline CD34+ counts, higher doses of G-CSF might improve mobilization. Baseline CD34+ counts and total G-CSF dose accounted for less than half of the variation in CD34+ cells collected, which indicates that other, as yet unidentified, factors play an important role in determining the effectiveness of mobilization.

    View details for Web of Science ID A1997XV77700006

    View details for PubMedID 9294469

  • Relationship between leukocyte count and patient risk for excessive blood loss after cardiac surgery CRITICAL CARE MEDICINE Despotis, G. J., Levine, V., GOODNOUGH, L. T. 1997; 25 (8): 1338-1346


    To evaluate the relationship between leukocyte counts and risk for excessive blood loss after cardiac surgery when including numerous demographic, operative, and laboratory factors in the comparison.A prospective, clinical evaluation.A point-of-care laboratory and the cardiac surgical unit of a university-affiliated tertiary center.Patient-related and hematologic variables were measured, using blood specimens obtained from 89 hospitalized patients who underwent cardiac surgery involving cardiopulmonary bypass.None.Demographic, operative, and transfusion-related data were recorded for each patient. Routinely obtained measurements of laboratory-based prothrombin time, partial thromboplastin time, complete blood count, and bleeding time were recorded. Hemoglobin concentration, platelet count, and red and white blood cell counts were measured with an on-site instrument before initiation (pre-cardiopulmonary bypass) and before discontinuation (end-cardiopulmonary bypass) of cardiopulmonary bypass. Hematocrit was calculated using recorded variables, and white blood cell percent change values were calculated using white blood cell counts from both periods, using the following formula: [(end-cardiopulmonary bypass - pre-cardiopulmonary bypass)/pre-cardiopulmonary bypass] x 100. When we excluded four patients who had a surgical source of post-cardiopulmonary bypass bleeding, significant (p < .0001) relationships were observed between white blood cell count (r2 = .46) and white blood cell percent change values (r2 = .71) and cumulative mediastinal chest tube drainage in the first 4 postoperative hours in 85 patients. Bayes theorem was used to evaluate the predictive ability of hematologic measurements in identifying patients with excessive bleeding (n = 24), defined as >1000 mL of cumulative chest tube drainage in the first 24 postoperative hours, when compared with patients without excessive bleeding (n = 61). Demographic and operative variables were similar between these patients except that patients with excessive bleeding required more red blood cell, platelet, and plasma transfusions during the postoperative interval. Significantly (p < .0001) greater white blood cell percent change values were obtained in the excessive bleeding cohort (119 +/- 93 percent change) when compared with patients without excessive bleeding (28 +/- 36 percent change).On-site measurements of white blood cell count, as an index of the inflammatory response to extracorporeal circulation, may be useful in identifying patients at increased risk for excessive bleeding. Further studies are needed to examine whether white blood cell counts during multiple cardiopulmonary bypass periods may identify patients with an exaggerated inflammatory response to extracorporeal circulation. By using this information, physicians may be able to intervene with anti-inflammatory medications and blood preservation techniques.

    View details for Web of Science ID A1997XQ99400021

    View details for PubMedID 9267947

  • Whole blood heparin concentration measurements by automated protamine titration agree with plasma anti-Xa measurements JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY Despotis, G. J., Joist, J. H., GOODNOUGH, L. T., Santoro, S. A., Spitznagel, E. 1997; 113 (3): 611-613

    View details for Web of Science ID A1997WP59100031

    View details for PubMedID 9081112

  • Evaluation of a new point-of-care test that measures PAF-mediated acceleration of coagulation in cardiac surgical patients ANESTHESIOLOGY Despotis, G. J., Levine, V., Filos, K. S., Santoro, S. A., Joist, J. H., Spitznagel, E., GOODNOUGH, L. T. 1996; 85 (6): 1311-1323


    This study was designed to evaluate a new point-of-care test (HemoSTATUS) that assesses acceleration of kaolin-activated clotting time (ACT) by platelet activating factor (PAF) in patients undergoing cardiac surgery. Our specific objectives were to determine whether HemoSTATUS-derived measurements correlate with postoperative blood loss and identify patients at risk for excessive blood loss and to characterize the effect of desmopressin acetate (DDAVP) and/or platelet transfusion on these measurements.Demographic, operative, blood loss and hematologic data were recorded in 150 patients. Two Hepcon instruments were used to analyze ACT values in the absence (channels 1 and 2: Ch1 and Ch2) and in the presence of increasing doses of PAF (1.25, 6.25, 12.5, and 150 nM) in channels 3-6 (Ch3-Ch6). Clot ratio (CR) values were calculated with the following formula for each respective PAF concentration: clot ratio = 1-(ACT/control ACT). These values also were expressed as percent of maximal (%M = clot ratio/0.51 x 100) using the mean CRCh6 (0.51) obtained in a reference population.When compared with baseline clot ratios before anesthetic induction, a marked reduction in clot ratios was observed in both Ch5 and Ch6 after protamine administration, despite average platelet counts greater than 100 K/microliter. There was a high degree of correlation between clot ratio values and postoperative blood loss (cumulative chest tube drainage in the first 4 postoperative hours) with higher concentrations of PAF: CRCh6 (r = -0.80), %M of CRCh6 (r = -0.82), CRCh5 (r = -0.70), and %M of CRCh5 (r = -0.85). A significant (P < 0.01) improvement in clot ratios was observed with time after arrival in the intensive care unit in both Ch5 and Ch6, particularly in patients receiving DDAVP and/or platelets.Activated clotting time-based clot ratio values correlate significantly with postoperative blood loss and detect recovery of PAF-accelerated coagulation after administration of DDAVP or platelet therapy. The HemoSTATUS assay may be useful in the identification of patients at risk for excessive blood loss and who could benefit from administration of DDAVP and/or platelet transfusion.

    View details for Web of Science ID A1996VX62100013

    View details for PubMedID 8968178

  • More effective suppression of hemostatic system activation in patients undergoing cardiac surgery by heparin dosing based on heparin blood concentrations rather then ACT THROMBOSIS AND HAEMOSTASIS Despotis, G. J., Joist, J. H., Hogue, C. W., ALSOUFIEV, A., JOINERMAIER, D., Santoro, S. A., Spitznagel, E., Weitz, J. I., GOODNOUGH, L. T. 1996; 76 (6): 902-908


    This study was designed to determine whether the maintenance of higher than usual patient-specific heparin concentrations during cardiopulmonary bypass (CPB) was associated with more effective suppression of hemostasis system activation. Thirty-one patients scheduled for repeat cardiac surgery or combined procedures (i.e., coronary revascularization + valve repair/replacement) were consented and enrolled in this study. All patients received porcine heparin and protamine and were randomly assigned to monitoring of anticoagulation by either celite ACT alone (Control, n = 16) or by kaolin ACT combined with on-site measurements of whole blood heparin concentration (Intervention, n = 15). Blood specimens collected before administration of heparin, before weaning from CPB and after administration of protamine were analyzed with a battery of coagulation assays. Patients in the intervention cohort received appreciably greater heparin doses than control patients, resulting in higher anti-Xa heparin levels at the end of CPB. Fibrinopeptide A and D-dimer levels were higher in the control group before discontinuation of CPB. Percent decrease during CPB were greater in the control group for factors V and VIII, fibrinogen and antithrombin III. Percent decrease in complement 3 was greater in the control group after protamine and bleeding times measured in the Intensive Care Unit were significantly more prolonged in this group. Maintenance of higher patient-specific heparin concentrations during CPB more effectively suppresses excessive hemostatic system activation than do standard heparin doses chosen based on measurement of ACT. These findings may explain, at least in part, the significant reduction in perioperative blood loss and blood product use when higher heparin concentrations are maintained.

    View details for Web of Science ID A1996VZ47800013

    View details for PubMedID 8972009

  • Utilization review for red cell transfusions - Are we just going through the motions? ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE GOODNOUGH, L. T., Audet, A. M. 1996; 120 (9): 802-803

    View details for Web of Science ID A1996VQ69000005

    View details for PubMedID 9140283

  • Improving the efficacy of preoperative autologous blood donation in patients with low hematocrit: a randomized, double-blind, controlled trial of recombinant human erythropoietin. American journal of medicine Price, T. H., GOODNOUGH, L. T., VOGLER, W. R., Sacher, R. A., HELLMAN, R. M., Johnston, M. F., Bolgiano, D. C., Abels, R. I. 1996; 101 (2A): 22S-27S


    The effects of therapy with recombinant human erythropoietin (Epoetin alfa) on erythropoiesis, preoperative autologous blood donation, and risk of exposure to allogeneic blood were evaluated in 204 patients scheduled to undergo elective orthopedic surgery. Study protocol required patients to have a baseline hematocrit < or = 39% and surgery scheduled 25-35 days in advance. Patients were randomized to two equal groups and were seen at study centers every 3-4 days within the 21-day trial period. At each visit, phlebotomy(< or = 450 mL) was performed if the hematocrit was > or = 33%, and Epoetin alfa (600 U/kg) or placebo was administered intravenously. A total of 173 patients were assessable; 31% of placebo recipients and 20% of Epoetin alfa recipients required allogeneic transfusion (p = 0.09). Logistic regression modeling showed that the risk of allogeneic transfusion was reduced by Epoetin alfa (p = 0.025). When patients receiving > 6 units of blood (necessitating allogeneic units) were excluded from analysis, 29% of placebo recipients and 14% of Epoetin alfa recipients were exposed to allogeneic blood (p = 0.015). Epoetin alfa recipients predonated more autologous units than did placebo recipients (4.5 vs 3.0 units, respectively; p < 0.001), and their production of red blood cells increased significantly more over baseline production values (668 vs 353 mL, respectively; p < 0.05). These results demonstrate that administration of Epoetin alfa stimulates erythropoiesis, allows predonation of more units of autologous blood, and reduces the risk of exposure to allogeneic blood. Optimal dosing regimens and surgical patients most likely to benefit fro Epoetin alfa therapy must be established.

    View details for PubMedID 8928704

  • Evolving concepts in autologous blood procurement and transfusion: case reports of perisurgical anemia complicated by myocardial infarction. American journal of medicine GOODNOUGH, L. T., Monk, T. G. 1996; 101 (2A): 33S-37S

    View details for PubMedID 8831427

  • Intraoperative salvage in patients undergoing elective abdominal aortic aneurysm repair: An analysis of cost and benefit JOURNAL OF VASCULAR SURGERY GOODNOUGH, L. T., Monk, T. G., Sicard, G., Satterfield, S. A., Allen, B., Anderson, C. B., Thompson, R. W., Flye, W., Martin, K. 1996; 24 (2): 213-218


    Although autologous blood procurement has become a standard of care in elective surgery, recent studies have questioned its cost-effectiveness. We therefore reviewed our 3-year experience with intraoperative cell salvage in patients who underwent elective abdominal aortic aneurysm repair.A 3-year retrospective chart review of elective abdominal aortic aneurysm (infrarenal and suprarenal) repair was performed. Transthoracic repairs were excluded.Estimated blood lost was 1748 +/- 1236 ml, or 35% of baseline blood volume (5012 +/- 689 ml). Overall, 164 (89%) received red blood cell (RBC) transfusions (3.5 +/- 2.0 U/patient). The cost per patient for cell salvage was $315 +/- $97, representing 31% of all RBC costs and 24% of total blood component costs. Mean salvage volume infused was 578 +/- 600 ml; at a mean hematocrit level of 55.7% the RBC volume infused from salvage during surgery was 313 +/- 328 ml (representing 27% of total RBC volume lost during the hospital stay). This mean RBC volume salvaged represented the equivalent of 1.6 blood bank RBC units. The mean blood bank costs saved by using cell salvage was $248, or 79% of the $315 actually spent for salvage. We found no decrease in percentage of patients undergoing transfusion until salvage volumes that were infused exceeded 750 ml, or the equivalent of two blood bank units; all of these patients who benefitted had estimated blood lost > or = 1000 ml.We conclude that use of intraoperative cell salvage was most beneficial for patients who had estimated blood loss greater than or equal to 1000 ml and cell salvage volumes infused greater than or equal to 750 ml. Patients who are estimated to lose less than 1000 ml receive little benefit yet incur substantial costs from intraoperative cell salvage.

    View details for Web of Science ID A1996VD22300005

    View details for PubMedID 8752031

  • Recurrent thrombosis of biventricular-support devices associated with accelerated intravascular coagulation and increased heparin requirements JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY Despotis, G. J., Levine, V., ALSOUFIEV, A., Joist, H., GOODNOUGH, L. T., Pasque, M. 1996; 112 (2): 538-540

    View details for Web of Science ID A1996VC10200044

    View details for PubMedID 8751525

  • Evaluation of complete blood count results from a new, on-site hemocytometer compared with a laboratory-based hemocytometer CRITICAL CARE MEDICINE Despotis, G. J., ALSOUFIEV, A., Hogue, C. W., Zoys, T. N., GOODNOUGH, L. T., Santoro, S. A., KATER, K. M., Barnes, P., Lappas, D. G. 1996; 24 (7): 1163-1167


    To compare point-of-care results obtained from an on-site hemocytometer with values provided by an institutional laboratory instrument.A prospective laboratory evaluation.The central laboratory and cardiac surgical intensive care unit of a university-affiliated tertiary care center.Normal range comparison was performed using blood specimens routinely obtained from 48 hospitalized patients for complete blood count analysis. The second evaluation was performed on blood specimens routinely obtained (in the intensive care unit) after cardiac surgery involving extracorporeal circulation in a series of 187 consecutive patients.Hemoglobin concentration, platelet count, mean corpuscular volume, mean platelet volume, and red and white blood cell counts were measured with both on-site (MD 16, Coulter Electronics, Hialeah, FL) and laboratory (STKS, Coulter Electronics) instruments. Hematocrit and red cell distribution width were calculated using measured variables. Blood specimens were obtained from two distinct patients series. To evaluate measurement values within the normal range, a series of 48 routinely obtained blood specimens for complete blood count analysis in our institutional laboratory were utilized for concurrent analysis with the on-site hemocytometer. To evaluate measurement values out of the normal range, a second comparison involved measurements performed on blood specimens obtained in the cardiac surgical intensive care unit for complete blood count analysis. Linear regression demonstrated good correlations between on-site and laboratory hemoglobin concentration (r2 = .97), hematocrit (r2 = .95), platelet count (r2 = .97), mean corpuscular volume (r2 = .91), red cell distribution width (r2 = .80), and red (r2 = .95) and white (r2 = .96) blood cell count results. A marginal correlation was observed between mean platelet volume values (r2 = .47). Bias analysis (mean +/- 2 SD) demonstrated similar measurements between on-site and laboratory hemoglobin concentration, hematocrit, platelet count, red blood cell count, white blood cell count, mean platelet volume, mean corpuscular volume, and red cell distribution width.On-site hemoglobin concentration, hematocrit, white blood cell count, red blood cell count, red cell distribution width, and platelet count values compare well with those results obtained from the laboratory. The MD 16 hemocytometer (Coulter Electronics) provides on-site hematologic results that can provide an accurate and rapid quantitative assessment of platelets, and red and white blood cells. Rapid access to information obtained from this type of system may be clinically useful, especially in critically ill patients.

    View details for Web of Science ID A1996UX03500016

    View details for PubMedID 8674329

  • Determinants of red cell, platelet, plasma, and cryoprecipitate transfusions during coronary artery bypass graft surgery: The Collaborative Hospital Transfusion Study TRANSFUSION Surgenor, D. M., Churchill, W. H., Wallace, E. L., Rizzo, R. J., Chapman, R. H., McGurk, S., Bertholf, M. F., GOODNOUGH, L. T., Kao, K. J., KOERNER, T. A., Olson, J. D., Woodson, R. D. 1996; 36 (6): 521-532


    Very little is known about the determinants of blood transfusions in patients undergoing coronary artery bypass graft surgery.To identify factors that influenced the transfusion of red cells, platelets, plasma, and cryoprecipitate, statistical methods were used to study 2476 consecutive diagnosis-related group 106 and 107 patients in five teaching hospitals who underwent coronary artery bypass surgery between January 1, 1992, and June 30, 1993.The likelihood of red cell transfusion was significantly associated with 10 preoperative factors: 1) admission hematocrit, 2) the patient's age, 3) the patient's gender, 4) previous coronary artery bypass surgery, 5) active tobacco use, 6) catheterization during the same admission, 7) coagulation defects, 8) insulin-dependent diabetes with renal or circulatory manifestations, 9) first treatment of new episode of transmural myocardial infarction, and 10) severe clinical complications. Platelet and/or plasma transfusions were strongly associated with the dose of red cells transfused. Transfusion requirements and other in-hospital outcomes were associated with patient characteristics, surgical procedure (reoperation vs. primary procedure), and the conduits used for revascularization (venous graft only, venous and internal mammary artery graft, or internal mammary artery graft only). Blood resource use and donor exposures were evaluated with respect to the risk to patients of contracting hepatitis C virus and human immunodeficiency virus infections.The classification of coronary artery bypass graft patients on the basis of attributes known preoperatively and by conduits used yields subsets of patients with distinctly different transfusion requirements and in-hospital outcomes.

    View details for Web of Science ID A1996UV83100009

    View details for PubMedID 8669084

  • Current red blood cell transfusion practices. AACN clinical issues GOODNOUGH, L. T. 1996; 7 (2): 212-220


    The appropriate use of blood transfusions remains variable among health-care institutions and patient populations. Transfusion practices are discussed in this article in relation to medical practice guidelines and utilization review. Specific transfusion practices in the settings of intensive care, orthopedic surgery, and open heart surgery are reviewed. A new, promising approach to improving transfusion outcomes is the use of transfusion algorithms. Transfusion algorithms may prove especially useful if they incorporate point-of-care testing that is both physiologic and patient-specific for transfusion decisions. Transfusion algorithms are discussed and data presented for cardiac surgical adults.

    View details for PubMedID 8718383

  • Response of kaolin ACT to heparin: Evaluation with an automated assay and higher heparin doses ANNALS OF THORACIC SURGERY Despotis, G. J., ALSOUFIEV, A. L., Spitznagel, E., GOODNOUGH, L. T., Lappas, D. G. 1996; 61 (3): 795-799


    Because previous reports suggest that the linear relationship between celite activated clotting time (ACT) values and heparin sodium is disrupted if values exceed 500 to 600 seconds, this study was designed to evaluate the relationship of kaolin activated clotting time (ACT) values to high in vitro heparin concentrations. In addition, the relationship of kaolin ACT to heparin concentration as determined manually was compared with that obtained with an automated heparin dose response assay.Blood specimens were obtained prior to and after heparin administration from 41 cardiac surgical patients requiring cardiopulmonary bypass in this institutional human studies committee-approved study. Five ACT instruments were used to evaluate the response of kaolin ACT to manually added heparin at two anticoagulation levels: low range (ACT values of less than 500 seconds) and high range (ACT values of 500 seconds or greater). Specimens were also used to measure kaolin ACT values at three heparin concentrations with an automated heparin dose response assay (HDR) using a Hepcon instrument.A greater response of kaolin ACT to heparin was seen with high-range ACT values than low-range ACT values as illustrated by greater (p = 0.002) mean slope values (low range, 99 +/- 30 s/U/ mL; high range, 128 +/- 50 s/U/ml). Good correlations were obtained between heparin concentration and either low- or high-range ACT values as demonstrated by mean correlation coefficients (low range, 0.992; high range 0.982). The response of low-range kaolin ACT values to heparin was greater than that obtained with the automated heparin dose response assay as illustrated by greater (p = 0.005) mean slope values (low range, 99 +/- 30 s/U/mL; HDR, 82 +/- 21 s/U/mL). Good correlations were observed for the relationship between heparin and ACT values obtained with the HDR assay (r = 0.998).A variable response of kaolin ACT to heparin among patients was demonstrated in our study, especially when ACT values exceeded 500 seconds. We found that the response of kaolin ACT to higher heparin concentrations was acceptable for clinical monitoring based on good correlations obtained in individual patients. The HDR assay generally overestimates a patient's heparin requirements; most likely, this is due to a lower response of kaolin ACT to heparin concentration that is reflected in this assay. Because and exceptional correlation can be obtained between kaolin ACT values and heparin concentration using the assay, this automated assay can identify heparin-resistant patients who may need further treatment.

    View details for Web of Science ID A1996TY99600007

    View details for PubMedID 8619695

  • Evaluating the appropriateness of red blood cell transfusions: The limitations of retrospective medical record reviews INTERNATIONAL JOURNAL FOR QUALITY IN HEALTH CARE Audet, A. M., GOODNOUGH, L. T., Parvin, C. A. 1996; 8 (1): 41-49


    Several studies have looked at the appropriateness of red blood cell transfusions, using retrospective chart reviews to assess compliance with guidelines. The goal of this study was to determine the quality of medical chart documentation, and assess the validity and the feasibility of using retrospective chart review data as part of a quality improvement (QI) program, to evaluate the appropriateness of peri-operative transfusions.The charts of 188 patients admitted for elective orthopedic surgery were reviewed. Both intra-operative and post-operative transfusion events (n = 353) were analyzed.Only 68% of post-operative transfusion events on the day of surgery and 35% of transfusion events on days after surgery were accompanied by documentation of blood loss and/or change in vital signs. Symptoms were recorded in only 10% of post-operative transfusion events. The rationale for transfusion was recorded in only 16% of post-operative transfusion events on the day of surgery, in 27% on post-operative days and in 95% of intra-operative transfusions. The documentation of rationale was not different for transfusion events involving autologous blood (31%) or allogeneic blood (32%). This study provided information on transfusion practices. Single unit transfusions occurred in only 47 and 34% of patients receiving autologous and allogeneic blood, respectively. Only 19% of patients transfused with more than one allogeneic blood units, were clinically reassessed between blood units, compared to 34% of patients receiving more than one autologous blood unit. We conclude that retrospective chart reviews are limited by inadequate documentation and may not be the optimal source of information to determine the appropriateness of a transfusion. Improved methods (e.g. prospective reviews, or other system-level data collection methods) are needed for QI programs to influence practice. Despite its limitations, the information obtained suggests that current practice could be improved.

    View details for Web of Science ID A1996UA20800006

    View details for PubMedID 8680816

  • Autologous blood procurement in the surgical setting: Lessons learned in the last 10 years VOX SANGUINIS GOODNOUGH, L. T., Monk, T. G., Brecher, M. E. 1996; 71 (3): 133-141


    The percentage of blood transfused yearly that is autologous has increased substantially over the last 10 years. While autologous blood is regarded as a standard of care in many elective surgical settings, the increasing safety of allogeneic blood and the expense of autologous blood procurement have raised question regarding the appropriate roles of autologous blood in blood conservation strategies. We therefore review current activities and emerging questions that arise from this maturing arena.

    View details for Web of Science ID A1996VM63800001

    View details for PubMedID 8912455

  • Stratifying patients preoperatively for transfusion outcomes ANNALS OF THORACIC SURGERY GOODNOUGH, L. T. 1996; 61 (1): 8-9

    View details for Web of Science ID A1996TR81800002

    View details for PubMedID 8561643

  • The effect of recombinant human erythropoietin on the efficacy of autologous blood donation in patients with low hematocrits: A multicenter, randomized, double-blind, controlled trial TRANSFUSION Price, T. H., GOODNOUGH, L. T., VOGLER, W. R., Sacher, R. A., HELLMAN, R. M., Johnston, M. F., Bolgiano, D. C., Abels, R. I. 1996; 36 (1): 29-36


    This randomized controlled study was undertaken to determine the effect of recombinant human erythropoietin (rHuEPO) on erythropoiesis, autologous blood collection, and allogeneic transfusion risk in elective surgery patients with low baseline hematocrits.Patients (n = 204) with low baseline hematocrits ( < or = 39%), scheduled for orthopedic surgery within 25 to 35 days, were seen every 3 to 4 days for 21 days. At each visit, 450 mL of blood was collected if the hematocrit was > or = 33 percent, and rHuEPO (600 U/kg) or placebo was administered intravenously.One hundred seventy-three patients were evaluable. The number of autologous units collected from the rHuEPO and control groups, respectively, was 4.5 +/- 1.0 and 3.0 +/- 1.1 (p < 0.001), and marrow production of red cells increased by 668 +/- 222 and 353 +/- 155 mL over and above baseline production (p < 0.05). Allogeneic blood transfusion was required by 31 percent of control and 20 percent of rHuEPO patients (p = 0.09). Excluding 8 patients who received > 6 units, 29 percent of control and 14 percent of rHuEPO patients required allogeneic blood (p = 0.015). Logistic regression modeling determined that the risk of allogeneic transfusion was reduced by rHuEPO (p = 0.025).The use of rHuEPO stimulates erythropoiesis, permits the storage of more autologous blood, and reduces allogeneic transfusion risk in patients with low hematocrits who are undergoing elective orthopedic surgery. Additional studies are necessary to determine the optimal schedules of rHuEPO administration and autologous blood collection as well as the cost-effectiveness of this strategy.

    View details for Web of Science ID A1996TV89000005

    View details for PubMedID 8607150

  • Establishing practice guidelines for surgical blood management. American journal of surgery GOODNOUGH, L. T., Despotis, G. J. 1995; 170 (6A): 16S-20S


    Medical practice guidelines have been promoted as a way to improve the cost-effectiveness of medical care. Algorithms for the transfusion of red blood cells, plasma, and platelets may be especially useful in the surgical setting if they incorporate point-of-care information that is both physiologic and patient-specific for transfusion decision making. Therefore, the goals of guidelines for surgical blood management should be twofold. They should (1) acknowledge patient-specific variability while addressing physician- and institution-dependent variables; and (2) improve blood component management by developing more physiologic clinical indicators of the need for allogeneic red blood cell transfusion.

    View details for PubMedID 8546241

  • Blood conservation strategies to minimize allogeneic blood use in urologic surgery. American journal of surgery Monk, T. G., GOODNOUGH, L. T. 1995; 170 (6A): 69S-73S


    Analysis of the net costs, efficacy, and cost-effectiveness of preoperative autologous blood donation (PAD), versus acute normovolemic hemodilution (ANH), in patients undergoing radical prostatectomy is presented. Currently, PAD is a standard of care for patients undergoing radical prostatectomy. Comparison of PAD with ANH showed no differences in risks or outcome, but ANH was less expensive. Hemodilution is a simple, safe, convenient, and effective alternative to PAD. The use of recombinant human erthropoietin in conjunction with PAD and ANH has optimized perioperative hematocrits and further minimized exposure to allogeneic blood. Intraoperative blood salvage, lower transfusion triggers, and other blood conservation strategies are discussed. The most cost-effective techniques currently available for decreasing allogeneic blood transfusions appear to be avoidance of blood loss, increased tolerance for decreased HCT levels, and autologous blood procurement via ANH.

    View details for PubMedID 8546252



    Aprotinin is being used increasingly to limit cardiopulmonary bypass (CPB)-induced coagulation derangements. Since whole blood prothrombin time (PT) and activated partial thromboplastin time (APTT) assays are beneficial in the treatment of bleeding after CPB, we studied the potential effect of aprotinin on these whole blood assays. Blood specimens from 151 cardiac surgical patients were obtained in two phases: prior to heparin administration, before CPB, and subsequent to heparin neutralization after CPB. After collection, blood specimens were divided into two aliquots and mixed with either normal saline (NS) or aprotinin (A, 200 or 400 Kallikrein inhibiting units (KIU)/mL). Whole blood specimens were used to measure whole blood PT and APTT using CoaguChek Plus instruments. Whole blood PT results were similar between normal saline. (NS)- and aprotinin-spiked specimens before CPB (A, 12.9 +/- 1.5s; NS, 12.8 +/- 1.5s; P = 0.76) and after CPB (A, 17.5 +/- 2.4s; NS, 17.7 +/- 2.4s; P = 0.58). In contrast, whole blood APTT results were prolonged in aprotinin-spiked specimens prior to CPB (A, 63.3 +/- 32.2s; NS, 38.6 +/- 16.3s; P < 0.0001) and after CPB (A, 65.9 +/- 23.7s; NS, 45.7 +/- 14.4s; P < 0.0001). A dose-dependent prolongation of whole blood APTT by aprotinin was demonstrated by a greater mean difference in APTT (P = 0.0001) between specimens spiked with NS or 200 KIU (17.5 +/- 12.2s) vs 400 KIU (27.8 +/- 21.5s) of aprotinin.(ABSTRACT TRUNCATED AT 250 WORDS)

    View details for Web of Science ID A1995TC51900005

    View details for PubMedID 7486078



    Treatment outcomes of sensory-motor polyneuropathies associated with anti-myelin-associated glycoprotein (MAG) antibodies have varied even with relatively intensive immunosuppression. We used plasma exchange and cyclophosphamide to treat four patients with anti-MAG antibody-associated polyneuropathies whose symptoms had progressed in the preceding year. Treatment courses consisted of five to seven monthly regimens of plasma exchange on 2 consecutive days followed by intravenous cyclophosphamide (1 g/m2). Effects of treatment were quantitatively measured with hand-held dynamometry. All four patients showed improvement in both strength and sensation in the 5 to 24 months after treatment. We conclude that selected patients with sensory-motor polyneuropathies associated with high-titer serum IgM autoantibodies against MAG may have quantitative and useful functional improvement after immunotherapy. The improvement continues after completion of treatment and may persist for 1 to 2 years or longer.

    View details for Web of Science ID A1995RP30400027

    View details for PubMedID 7543988



    Guidelines for transfusion practice have had limited impact in altering physician transfusion behavior in patients undergoing cardiac operations. This may be due to a lack of consensus on the relative risks and benefits of blood in these patients who are anemic, limited access to timely data that are necessary on which to base transfusion decisions, the recognition that empiric hemoglobin/hematocrit thresholds are limited clinical indicators of the need for blood, or a combination of these. We present an overview of current transfusion and blood conservation practices in this setting, along with possible approaches to guide the decision-making process by coupling the use of transfusion algorithms with point of care testing to use more physiologic indicators of the need for blood transfusion.

    View details for Web of Science ID A1995RQ58300058

    View details for PubMedID 7646127



    The endogenous erythropoietin (EPO) response and the erythropoietic response to anemia in the elderly, as compared with that in younger subjects, is controversial. We therefore studied autologous blood donors undergoing aggressive phlebotomy to determine the effect of age and gender on the EPO response to blood loss anemia, along with the erythropoietic response to endogenous EPO and to exogenous recombinant human EPO therapy. Seventy-one patients underwent phlebotomy, up to 6 units over 3 weeks, and received either placebo (n = 18), EPO 150 U/kg (n = 16), EPO 300 U/kg (n = 18), or EPO 600 U/kg (n = 19) at each of the six visits. Linear regression analysis of the hemoglobin/log EPO relationship for 18 placebo patients revealed no differences in the endogenous EPO response to phlebotomy, as determined by the slopes and intercepts, for males versus females or as a function of age. We found no differences in endogenous EPO-stimulated red blood cell (RBC) volume expansion for males and females (7.06 +/- 2.4 and 7.22 +/- 2.2 ml/kg, respectively, p = 0.88) or as a function of age (estimated rate of change = -0.58 +/- 0.33 ml/kg for every 10 years of life, p = 0.10). Similarly, we found no differences in RBC response to EPO for males versus females (1.4 +/- 0.3 ml/kg vs 1.5 +/- 0.3 ml/kg per 1000 U/kg EPO, respectively, p = 0.80) or as a function of age (estimated rate of change = 0.051 +/- 0.15 ml/kg per 1000 U/kg EPO for every 10 years of life, p = 0.74).(ABSTRACT TRUNCATED AT 250 WORDS)

    View details for Web of Science ID A1995RG55600009

    View details for PubMedID 7602235



    Preoperative autologous blood donation is accepted as a standard of care for radical prostatectomy. Acute normovolemic hemodilution (ANH) is an alternative method for obtaining autologous blood. The cost and benefits of these two autologous blood-collection techniques are compared.Thirty consecutive patients scheduled for radical prostatectomy underwent ANH to a target hematocrit level of 28 percent. Blood was transfused in the perioperative period to maintain the hematocrit level > 25 percent. Hematocrit levels, transfusion outcomes and costs, and postoperative outcomes for these patients (hemodilution group) were compared with a matched patient cohort who preoperatively donated 3 units of blood for autologous use in prostatectomy surgery (nonhemodilution group, n = 30).Thirty patients underwent ANH to a hematocrit level of 28.7 +/- 1.7 percent, and 1740 +/- 346 mL (3.5 +/- 0.7 units) of blood were collected. Three (10%) of the patients in each cohort had allogeneic blood exposure. Transfusion costs were 73 percent higher for the nonhemodilution group patients than for the hemodilution group patients ($330 +/- $100 vs. $191 +/- $55, p < 0.001). No differences were found in postoperative outcomes.An integrated blood conservation program utilizing hemodilution and a defined transfusion trigger can decrease the requirement for preoperative donation of blood for autologous use in radical prostatectomy. Point-of-care autologous blood procurement is more cost-effective than preadmission donation of autologous blood units.

    View details for Web of Science ID A1995RJ26100006

    View details for PubMedID 7631387

  • The relationship between hematocrit, blood lost, and blood transfused in total knee replacement. Implications for postoperative blood salvage and reinfusion. The American journal of knee surgery GOODNOUGH, L. T., Verbrugge, D., Marcus, R. E. 1995; 8 (3): 83-87


    The relationship between patient hematocrit level, red blood cell volume lost, and blood units transfused is important in determining conservation strategies in patients undergoing total knee replacement surgery. In a series of 30 such patients, 3 (10%) received allogeneic blood, despite preoperative autologous blood donation in 28 patients. There was no evidence that the degree of anemia affected rate or volume of postoperative wound blood drainage. The wound drainage volume that could have been salvaged and reinfused in bilateral procedures was substantial. A combination of one or more conservation techniques along with conservative transfusion practice is necessary to achieve minimal allogeneic blood exposure.

    View details for PubMedID 7552610

  • The use of erythropoietin in the enhancement of autologous transfusion therapy. Current opinion in hematology GOODNOUGH, L. T. 1995; 2 (3): 214-218


    In the case of elective surgery requiring transfusion, preoperative autologous blood donation offers an attractive alternative to allogeneic blood transfusion. Although previously underutilized, autologous donation has become a standard of care in several elective surgical procedures, resulting in a significant increase in the percentage of blood collected nationally that is autologous. Potential candidates for autologous blood donation prior to elective surgery include any patient for whom blood type and crossmatch are requested, indicating a likelihood of requiring blood transfusion according to a maximum surgical blood ordering schedule. Utilization of autologous donation before elective surgery has increased with coordinated programs involving regional blood centers, hospital blood banks, information services, and physicians. The impact of physician ordering and autologous blood procurement practices on subsequent allogeneic blood transfusions must be understood in order to address the role of aggressive autologous blood procurement, including the role of recombinant human erythropoietin in blood conservation strategies.

    View details for PubMedID 9371998



    Recombinant human growth factors are expected to have a significant impact on the use of allogeneic blood components. For example, subsequent to the approval of recombinant human erythropoietin, blood transfusions in renal dialysis patients declined substantially. Likewise, myeloid growth factors have reduced infections and hospital stay by promoting hematologic recovery after high dose ablative chemotherapy. The high costs of these agents mandate that their use be limited to settings where they are clinically indicated. The use of growth factors may be monitored at medical centers by hospital transfusion committees. This chapter reviews the emerging clinical guidelines for the use of hematopoietic growth factors.

    View details for Web of Science ID A1995QM02800006

    View details for PubMedID 10155704



    Twenty cardiac surgical patients requiring cardiopulmonary bypass were enrolled in this study designed to evaluate the effect of aprotinin on activated clotting time (kaolin and celite), whole blood, and laboratory-based plasma (anti-Xa) heparin measurements. Whole blood heparin measurements were not different (p = 0.98) between aprotinin-treated (3.2 +/- 2.8 U/mL) and control (3.2 +/- 3.0 U/mL) specimens. Plasma anti-Xa heparin measurements were also not different (p = 0.95) between aprotinin-treated (2.7 +/- 2.5 U/mL) and control (2.8 +/- 2.5 U/mL) specimens. The relationship between whole blood (plasma equivalent) and plasma heparin measurements was similar (p = 0.1) in the presence (slope, 1.04; r2 = 0.89) or absence (slope, 1.11; r2 = 0.89) of aprotinin. In contrast to weak correlations between celite (r = 0.50) or kaolin (r = 0.53) activated clotting time values, whole blood heparin measurements correlated well (r = 0.93) with plasma heparin measurements during cardiopulmonary bypass in the presence of aprotinin. These findings indicate that whole blood heparin measurements are unaffected by aprotinin and correlate well with plasma anti-Xa heparin measurements even in the presence of aprotinin. Therefore, the automated protamine titration assay can be used to monitor accurately heparin concentrations in patients receiving aprotinin.

    View details for Web of Science ID A1995QB32900021

    View details for PubMedID 7529483



    Previous reports suggest that activated clotting times do not correlate with heparin concentration during cardiopulmonary bypass. This study was designed to compare whole blood heparin concentration and activated clotting time measurements with laboratory-based plasma heparin concentration. Sixty-two patients having cardiac operations requiring cardiopulmonary bypass were enrolled in this study. The study was conducted in two phases. In phase I of this trial, blood specimens were obtained from 30 patients before heparin administration and after each of three heparin doses (20, 80, and 150 U/kg). In phase II, blood specimens were obtained from 32 patients before heparin administration and 10 minutes after each of the following: heparin administration (250 or 300 U/kg), initiation of cardiopulmonary bypass, achievement of hypothermia, initiation of rewarming, and immediately before discontinuation of bypass. Blood specimens were used to measure activated clotting time (kaolin and celite), whole blood heparin concentration, and anti-factor Xa plasma heparin concentration. In phase I, activated clotting time (celite: r = 0.91; kaolin: r = 0.93) and whole blood heparin concentration (r = 0.98) measurements correlated well with plasma heparin concentration. After initiation of cardiopulmonary bypass (phase II), weak correlations for activated clotting time measurements (celite: r = 0.34; kaolin: r = 0.59) and a strong correlation for whole blood heparin concentration (r = 0.95) were evident when compared with plasma heparin concentration. During bypass, activated clotting time measurements also inversely correlated with temperature (celite: r = -0.21; kaolin: r = -0.19) and hematocrit (celite: r = -0.26; kaolin: r = -0.21). A weak correlation between activated clotting time measurements and plasma heparin concentration is evident during the cardiopulmonary bypass period, probably because of the influence of both reduced hematocrit and temperature on the activated clotting time assay. In contrast, whole blood heparin measurements correlate well with plasma heparin concentration before and during bypass. Further studies are needed to determine whether maintaining heparin levels during cardiopulmonary bypass by monitoring heparin concentration is more effective in preventing consumptive activation of the hemostatic system, reducing bleeding, and minimizing the use of blood products after cardiopulmonary bypass when compared with a protocol based on activated clotting time.

    View details for Web of Science ID A1994PW58600010

    View details for PubMedID 7983877

  • The effect of recombinant human erythropoietin therapy on red cell expansion during autologous blood donation. Contemporary orthopaedics GOODNOUGH, L. T., Marcus, R. E. 1994; 29 (6): 430-434


    As the result of the institution of coordinated programs involving regional blood centers, hospital blood banks, information services, and physicians, preoperative autologous blood donation, a previously underutilized practice, has become a standard of care in a number of elective surgical procedures. In addition, the administration of recombinant human erythropoietin has been shown to facilitate the collection of autologous blood from patients scheduled for elective orthopaedic surgery. An analysis of the findings in a study of 263 orthopaedic surgical patients in which the relationship between autologous blood ordering, collection and storage, and subsequent blood transfusion was studied indicates that both blood ordering and blood procurement practices are significant factors with regard to allogeneic blood exposure.

    View details for PubMedID 10150254

  • Role of hematopoietic growth factors in transfusion medicine. Current opinion in hematology GOODNOUGH, L. T. 1994; 1 (6): 462-470


    Recombinant human growth factors are expected to have a significant impact on the use of allogeneic blood components. For example, recombinant human erythropoietin has had a significant impact on blood transfusion in renal dialysis patients. Likewise, myeloid growth factors have reduced infections and hospital stay by promoting hematologic recovery after high-dose ablative chemotherapy. The high costs of these agents mandate that their use be limited to settings where they are clinically indicated. This review discusses the emerging clinical data to help establish guidelines for the use of hematopoietic growth factors. Comments regarding the myeloid growth factors are restricted to their emerging role in stem cell transplantation, because this clinical setting is anticipated to have the greatest impact in the use of allogeneic blood components in oncology.

    View details for PubMedID 9371324



    Motor neuropathies associated with electrodiagnostic evidence of motor conduction block often improve after treatment with immunotherapy, but there is less evidence about the responsiveness of lower motor neuron (LMN) syndromes without conduction block. In this study we treated four patients with an asymmetric, predominantly distal LMN syndrome associated with high serum titers of IgM anti-GM1 ganglioside antibodies but without conduction block on electrodiagnostic testing. Treatment courses consisted of five to seven repeated monthly regimens of plasma exchange on 2 consecutive days followed, on day 3, by intravenous cyclophosphamide (1 g/m2). The results of treatment were quantitatively measured using hand-held dynamometry. We found that all four patients showed progressive improvement in strength over the 6 to 24 months following treatment. Improvement was documented by both objective muscle testing and patient reports of increased strength and less fatigability. We conclude that immunotherapy may be followed by useful functional benefit in selected patients with an asymmetric, predominantly distal LMN syndrome associated with high serum titers of IgM anti-GM1 antibodies. Gradual improvement often begins as late as 6 to 9 months after the onset of treatment and may persist for 1 to 2 years, or longer, after immunosuppressive treatment is stopped.

    View details for Web of Science ID A1994PR09500007

    View details for PubMedID 7969954



    Recombinant human erythropoietin (EPO) therapy as an alternative to allogenic blood transfusion has been studied extensively in the perisurgical period. The potential benefits of EPO in this setting are twofold; EPO enhances autologous blood collection in advance of elective surgery and stimulates erythropoiesis perioperatively. Clinical evidence of the role of EPO therapy in these settings to minimize allogenic blood exposure is presented.

    View details for Web of Science ID A1994PK87200012

    View details for PubMedID 7852209



    This study was designed to evaluate the potential in vitro use of heparinase to eliminate functionally active heparin prior to performing whole blood (WB) prothrombin time (PT) and activated partial thromboplastin time (APTT) assays. A total of 250 U/kg of heparin for cardiopulmonary bypass (CPB) was administered to 30 cardiac surgical patients in three consecutive, divided doses (20, 80, and 150 U/kg) at 15-min intervals. Blood specimens were obtained prior to heparin administration (baseline) and 10 min after each heparin dose. After collection, blood specimens were fractionated into three aliquots of which the first was used for determination of heparin concentration. After gentle mixing, WB PT and APTT measurements were performed for heparinase (Aliquot 2)- and nonheparinase (Aliquot 3)-treated blood. With consecutive heparin doses of 20 and 80 U/kg, WB PT increased from a baseline of 12.3 +/- 0.1 s to 13.3 +/- 0.2 and 18.5 +/- 1.3 s, while WB APTT increased from a baseline of 28.3 +/- 1.1 s to 89.5 +/- 5.4 after the initial heparin dose (20 U/kg). When compared to baseline (no heparin) results, small, progressive increases in heparinase-treated WB PT (0.7 +/- 0.1, 1.5 +/- 0.1, 2.1 +/- 0.1 s) and APTT (2.3 +/- 0.3, 5.7 +/- 0.4, 9.5 +/- 0.5 s) were seen with increasing heparin concentration (0.23, 1.58, and 3.95 U/mL, respectively). Heparinase was highly effective in eliminating the anticoagulant effects of even large amounts of heparin in plasma from cardiac surgical patients.(ABSTRACT TRUNCATED AT 250 WORDS)

    View details for Web of Science ID A1994PJ93200009

    View details for PubMedID 7943773



    Recombinant human erythropoietin (EPO) therapy has been shown to increase red blood cell (RBC) production and facilitate autologous blood donation before elective surgery. However, recent reports have suggested that surgery and/or EPO therapy may suppress endogenous erythropoietin secretion in response to anaemia. We therefore analysed the haemoglobin/erythropoietin relationship preoperatively and postoperatively in 71 autologous blood donors subjected to aggressive phlebotomy and six treatments with either EPO (150 U/kg, n = 16, 300 U/kg, n = 18, or 600 U/kg, n = 19) or placebo (n = 18). Using data from the three preoperative study visits, the linear relationship between log erythropoietin and haemoglobin was determined for each of the 18 placebo patients. We found no significant differences in the slopes of the relationships in this group during aggressive phlebotomy. Furthermore, there was no evidence of a significant difference in the erythropoietin level recorded postoperatively for each patient to that predicted from the patient's postoperative haemoglobin level, based on the haemoglobin/log erythropoietin relationship preoperatively. Similarly, for each of the EPO-treated groups, there was no evidence of a significant difference when comparing the recorded erythropoietin level to that predicted from each patient's postoperative haemoglobin level, based on the haemoglobin/log erythropoietin relationship preoperatively. We conclude that preoperative recombinant human erythropoietin therapy and/or surgery do not adversely affect the postoperative erythropoietin response to anaemia.

    View details for Web of Science ID A1994PB74000004

    View details for PubMedID 7986708



    To assess the efficacy and cost-effectiveness of preoperative autologous blood donation (PAD) in radical prostatectomy procedures.A retrospective 3-year review was performed of transfusion outcomes in radical prostatectomy procedures. Cost, benefits, and cost-effectiveness were established using a previously published Markov decision analysis model.Three hundred eighty-four (97%) of 394 patients predonated 3.5 +/- 0.6 (mean +/- SD) autologous blood units. Of these, 2.1 +/- 1.2 units (60%) were retransfused. Forty-two (11%) of 394 patients also received allogeneic blood. Autologous blood donors received only 0.2 +/- 0.6 allogeneic blood units, compared with 1.4 +/- 1.4 (p < 0.05) units transfused to patients who did not predonate. The net costs of PAD ranged from $83 to $303 per procedure. The life-expectancy benefit of PAD ranged from 0.05 to 0.07 days. The overall cost-effectiveness of PAD was estimated to be $1,813,000 per quality adjusted life-year saved. However, PAD was significantly more cost-effective for 2 unit donations ($531,000 per quality adjusted life-year saved).We conclude that autologous blood donation is an effective blood conservation strategy in elective radical prostatectomy. However, the cost-effectiveness of this practice compares unfavorably with that reported for other medical interventions. Alternative and more cost-effective strategies to reduce the need for allogeneic blood in this setting must be developed.

    View details for Web of Science ID A1994PA80200014

    View details for PubMedID 8048198



    Recombinant human erythropoietin (EPO) therapy has been known to enhance erythropoiesis and facilitate autologous blood donation before elective orthopedic operations. However, the optimal EPO dose in this setting remains undefined. To help determine this, we have examined the effect of patient weight and EPO dose on red blood cell (RBC) volume expansion.Forty-six nonanemic autologous blood donors enrolled at our institution in two previously reported multicenter clinical trials were analyzed. Patients received either placebo or EPO (150, 300, or 600 units [U] per kg) given intravenously at each of six AB blood type donation visits.Total preoperative RBC volume expansion over a 22 day period was 465 +/- 135 mL (mean +/- SD) in patients receiving a placebo and 588 +/- 201 mL, 735 +/- 144 mL, and 881 +/- 292 mL in patients receiving graded concentrations of EPO. When RBC volume increase was corrected for patient weight and EPO dose, patients receiving placebo or EPO (150, 300, and 600 U per kg) expanded RBC volume by 5.9 mL per kg in patients receiving placebo and 7.9, 9.1, and 10.9 mL per kg in patients receiving EPO, respectively (p < 0.02 for each EPO group compared with placebo group). A direct relationship between EPO dose and RBC volume increase (response) over 22 days was determined by the linear regression equation: RBC volume (mL per kg) = 6.34 + 0.0013X, r = 0.98, where X equals total units EPO administered (per kg body weight).We conclude that EPO dose can be based on anticipated blood losses and transfusion needs in autologous blood donors before orthopedic operation.

    View details for Web of Science ID A1994PA24600008

    View details for PubMedID 8044386


    View details for Web of Science ID A1994NW08700004

    View details for PubMedID 8035097

  • GUIDELINES FOR BLOOD UTILIZATION REVIEW TRANSFUSION Stehling, L., LUBAN, N. L., Anderson, K. C., Sayers, M. H., Long, A., Attar, S., Leitman, S. F., Gould, S. A., Kruskall, M. S., GOODNOUGH, L. T., HINES, D. M. 1994; 34 (5): 438-448


    Hospitals are required by accrediting agencies to perform blood utilization review. Specific areas that must be addressed are the ordering, distribution, handling, dispensing, and administration of blood components. Monitoring the effects of transfusion on patients is also required. The format of the review process and the criteria for appropriate blood utilization must be developed by each institution. This article provides examples of areas that can be reviewed and procedures that may be used. However, the suggested laboratory values must not be interpreted as defining indications or criteria for transfusion. Each transfusion committee, or its equivalent, is responsible for developing its own institutional blood utilization procedures and audit criteria. Review and approval by the medical staff prior to implementation are essential. The procedures must also be reviewed and revised on a regular basis.

    View details for Web of Science ID A1994NP05400016

    View details for PubMedID 8191570



    Despite published guideline and consensus conference recommendations, the role of acute preoperative hemodilution in elective surgery has not been defined. We performed a case study analysis of this technique in a large surgical program in order to estimate its degree of efficacy as practiced routinely, and to better define its role as a blood conservation strategy. Patients undergoing elective radical prostatectomy by one surgeon during a 3-yr period were analyzed retrospectively for blood loss, hematocrit levels, records of acute hemodilution, and transfusion outcomes. Patient blood volumes were determined by nomogram; final hematocrits after discrete blood volumes lost by surgery or by hemodilution were estimated. Sixteen (4.4%) of 410 total patients reviewed underwent hemodilution, representing 0 (0%), 4 (3%), and 12 (8%) of the 112, 146, and 152 patients undergoing surgery in years 1, 2, and 3, respectively. Median whole blood volume and mean red blood cell (RBC) volume removed by hemodilution was 1000 mL (range, 400-1500 mL) and 338 mL (range, 156-585 mL), respectively, representing 15% of patients' admission RBC volume. Net intraoperative RBC volume "saved" in losses by this technique was 95 mL (range, 25-204 mL), representing only 9.3% (range, 4%-17%) of total RBC volume lost during hospitalization. RBC volume removed by hemodilution constituted 34% (95-283 mL) of the total RBC volume transfused. We conclude that use of acute preoperative hemodilution remains in evolution and, as a single blood conservation intervention, contributes only modestly to blood conservation.

    View details for Web of Science ID A1994NJ08700017

    View details for PubMedID 8160993



    We have conducted a six-year (1986-1991) review of our transfusion service to identify the frequency of blood transfusions in patients undergoing chronic hemodialysis, before and after availability of recombinant human erythropoietin (EPO) as an alternative to allogeneic blood. Four hundred forty-nine patients who underwent a total of 54,929 dialysis events were reviewed. Overall, 343 (76%) of 449 patients received 4,864 red-cell transfusions during 54,929 dialysis events. Red-cell units transfused per patient were significantly lower in 1991 compared to the year (1988) prior to EPO (5.3 +/- 4.5, M+SD, vs 8.6 +/- 13.4, p = 0.02) but not compared to 1986 (6.4, p = 0.11). The frequency of red-cell transfusions per 100 dialysis events declined substantially when 1991 was compared to 1988 (4.11 vs 13.35, p < 0.01) but less so when 1991 was compared to 1986 (4.11 vs 6.20, p < 0.01). Overall, 4864 red-cell units transfused to dialysis patients accounted for 4.46% of 109,159 red-cell units released by our transfusion service, decreasing from 7.3% in 1988 to 2.0% in 1991. We conclude 1) the availability of EPO in 1989 was accompanied by a significant reduction in the frequency of red-cell exposure in patients undergoing dialysis from 1988, but the reduction was less impressive when compared to 1986. 2) Attention to EPO dosage, concomitant causes of anemia, and resistance to EPO therapy in this setting may be required to take full advantage of this biotechnologic alternative to blood transfusion.

    View details for Web of Science ID A1994NM65600009

    View details for PubMedID 8050211



    Inappropriate transfusion in cardiac surgery may, in part, be due to empiric transfusion therapy instituted in the absence of timely laboratory data. Therefore, the effect of a transfusion decision algorithm based on intraoperative coagulation monitoring of physicians' transfusion practice and the transfusion outcome was evaluated.In a randomized, controlled trial, cardiac surgical patients determined to have microvascular bleeding at the cessation of cardiopulmonary bypass were assigned to algorithm (A) or standard (S) therapy. Group A was treated with plasma and platelet therapy according to a transfusion algorithm based on on-site coagulation data available within 4 minutes. For Group S, the use of laboratory-based data and the decision to transfuse blood components were at physician discretion.Sixty-six patients were entered into the study (Group A, n = 30; Group S, n = 36). Other than the fact that there were significantly more female patients in Group S than in Group A, no differences between cohorts in regard to perioperative risk factors for blood transfusion needs were identified. Therefore, gender was factored in as a covariate in the statistical analysis. Group A patients received fewer hemostatic blood component units (p = 0.008) and had fewer total donor exposures (p = 0.007) during the entire hospitalization period. Linear regression analysis of the differences in slopes in Groups A and S for the relationships between the red cell volume lost and the red cell volume transfused (p < 0.03), non-red cell units transfused (p < 0.0001), and total number of blood components transfused (p < 0.0001) demonstrated that physicians' transfusion practice was significantly altered by the use of a transfusion algorithm with on-site coagulation data, independent of surgical blood losses.The use of algorithms by transfusion decision makers can serve as an effective physician education intervention.

    View details for Web of Science ID A1994NH36000003

    View details for PubMedID 8178325


    View details for Web of Science ID A1994NF05300001

    View details for PubMedID 8166583



    The aim here was to determine the effectiveness of a transfusion medicine educational intervention in a medicine core clerkship program. Third-year medical students enrolled in their medicine core clerkship rotations at tertiary care hospitals affiliated with our institution underwent a two-part educational intervention that incorporated a transfusion medicine curriculum within the context of the medicolegal, ethical and educational elements of informed consent. Part one was a 1-h didactic session on standards of practice for red blood cell transfusion. Part two was a 90-min multidisciplinary workshop on informed consent. The effectiveness of the educational intervention was analysed by an objective structured clinical evaluation. The student group receiving the educational intervention scored significantly higher than in the comparison group (65.8 +/- 9.2 vs. 54.1 +/- 10.56, P < 0.001). When student scores were used to determine changes in student response patterns over time, the largest change occurred in identifying possible other options to allogeneic blood transfusion. These results suggest that a transfusion medicine curriculum using an informed consent model can be used effectively as an educational intervention in a medicine core clerkship programme.

    View details for Web of Science ID A1994MY86800008

    View details for PubMedID 8012493



    Three cohorts of elective surgical patients were reviewed in order to develop a method in which the discharge haematocrit can serve as a clinical indicator for a subsequent study of the use of blood transfusion therapy. Three different levels of discharge haematocrit were evaluated: 36, 33, and 30% for 'generous', 'intermediate', and 'strict' criteria, respectively. Discharge haematocrits (%, mean +/- SD) for patients not transfused were 29.6 +/- 4.6, 33.7 +/- 5.0, and 33.6 +/- 3.4 for three different surgical groups (cardiac, orthopaedic, and urological surgical patients). When discharge haematocrits greater than 33% ('intermediate') were considered excessive due to previous transfusion, the prevalence of patients identified was 9, 6.5 and 13%, respectively. We found no relationship between the length of stay in hospital and the number of blood units transfused or patient discharge haematocrit levels. When the length of stay of patients identified by exceeding the clinical indicator was compared to that of patients not identified, orthopaedic and urological surgical patients showed no difference; however, cardiac surgical patients who exceeded the clinical indicator had shorter hospital stays compared to patients who were not so identified. We conclude the following: 1. The discharge haematocrit can be used as a clinical indicator for a subsequent review of use in order to evaluate the appropriateness of blood transfusion therapy. 2. The prevalence of patients identified who exceeded the clinical indicator, among three elective surgical patient groups, suggests that this indicator is applicable across elective surgical categories in order to target transfusion medicine education programmes and clinical outcome studies. 3. Additional factors important to the 'transfusion trigger', such as blood lost during hospitalization, may need to be included with the discharge haematocrit as clinical indicators in order to evaluate blood transfusion therapy in this setting.

    View details for Web of Science ID A1994MY86800006

    View details for PubMedID 8012491



    The contribution of autologous blood ordering and blood procurement practices on subsequent allogeneic blood exposure in elective orthopedic surgery must be understood to address the role of aggressive autologous blood procurement in blood conservation strategies. The authors examined the relationship between autologous blood ordering, blood collection, and subsequent allogeneic blood transfusion in orthopedic surgical patients. Of 263 consecutive autologous blood donors reviewed, 179 (68%) successfully donated the number of units requested (blood ordering cohort). Of these, 17 (9.5%) received allogenic blood. Of 84 patients unable to donate the units requested, 23 (27%) received allogeneic blood (blood procurement cohort). Allogeneic blood exposure in the blood ordering cohort occurred at the same prevalence for patients asked to donate < or = 3 units or > or = 4 units (10[6.8%] of 146 patients and 7[6%] of 116 patients, respectively). In contrast, only 3 (2%) of 146 patients asked to donate < or = 3 units received allogeneic blood in the blood procurement cohort, compared with 20 (17%) of 116 patients asked to donate > or = 4 units (P < .01). The greatest prevalence of allogeneic blood exposure occurred in 13 (35%) of 37 anemic (hematocrit level 39% at first donation) patients in the blood procurement cohort who could not donate > or = 4 units as requested. The study indicated that both blood ordering and blood procurement practices in autologous blood donation programs are important factors in blood conservation efforts to minimize allogeneic blood exposure.

    View details for Web of Science ID A1994NA12200025

    View details for PubMedID 8135195



    Mild increases in haematocrit (Hct) have been shown to enhance aerobic performance, but the effects of more severe increases have not been studied. Recombinant human erythropoietin (rHuEPO), which can cause substantial increases in haematocrit, was used to study the effects of induced severe polycythemia on aerobic endurance performance. Sixteen Sprague-Dawley rats were aerobically trained on motorized running wheels. After 5 weeks, the baseline aerobic endurance of each animal was determined by measuring the running time to exhaustion (RTE). Then each rat was randomly assigned to an experimental group (EXP) which received 600 U kg-1 rHuEPO every 3 days, or a placebo group (PLC). Haematocrit and animal mass were monitored for 3 weeks while training and treatment continued, and then the RTE was determined a second time. Results indicated that the rats in the treatment group had a significantly higher Hct (62.2% vs. PLC value of 47.3%, p < 0.001), but did not have a different RTE (75 min vs. PLC value of 73 min, p > 0.05) when compared to the placebo group. The change in the Hct compared to the change in RTE for each animal showed an inverse relationship (r = -0.8212), indicating that greater increases in rHuEPO induced polycythemia resulted in a decreased performance level. We conclude that rHuEPO-induced severe polycythemia was not accompanied by an increase in aerobic endurance in this animal model.

    View details for Web of Science ID A1994NC87100008

    View details for PubMedID 8171272



    A cluster of bacterial contamination of platelets occurred at a university hospital in a one-month period. This unusual clustering allowed us to examine the likely mechanism of contamination and clinical sequelae.We reviewed medical records of patients receiving random donor platelet transfusions to determine numbers of platelets transfused, reactions reported, and episodes of bacterial contamination. We also reviewed procedures at the collecting blood agencies and the hospital blood bank.Four patients received bacterially contaminated platelets during June and July 1991. The rates of reported platelet transfusion reactions increased significantly (P < 0.001) from September 1989 through July 1991 (study period); in addition, the rate of contamination of platelets during June and July 1991 was 23-fold higher than during the previous 21 months (P < 0.001). Surveillance methodology changed dramatically during the study period, contributing to the recognition of the current cluster. Pathogens isolated from the contaminated platelet pools were Bacillus cereus, Staphylococcus epidermidis, or Pseudomonas aeruginosa in titers ranging from 10(6) to 10(8) colony forming units/mL. Four constituent individual platelet units identified as the probable cause of the outbreak (including one postepidemic episode) were significantly older (mean age, 4.8 days) than 106 randomly selected individual platelet units (mean age, 3.7 days; P = 0.04). Platelet pools were transfused an average of 2.5 hours after pooling. Review of blood collection and platelet preparation practices did not identify breaks in procedure or technique that could have caused contamination.Increased awareness of platelet transfusion reactions by clinical staff and routine culturing of all platelets associated with transfusion reactions will identify contaminated platelets. Identification of contaminated platelets is necessary to treat affected patients appropriately and to determine the prevalence of and risk factors for contaminated platelets (Infect Control Hosp Epidemiol 1994;15:82-87).

    View details for Web of Science ID A1994MX05700007

    View details for PubMedID 8201239

  • The use of growth factors as alternatives to blood products Transfusion Science Goodnough LT 1994: 16


    Concern about the safety of the allogeneic blood supply has made preoperative autologous blood donation (PAD) routine before major noncardiac operations. However, the costs and benefits of PAD in elective coronary artery bypass grafting (CABG) are not well established. We used decision analysis to (1) calculate the cost-effectiveness of PAD in CABG, expressed as cost per year of life saved, and (2) compare the health benefits of reducing allogeneic transfusions with the potential risks of autologous blood donation by patients with coronary artery disease. A prospective study of 18 institutions provided data on transfusion practice and blood product costs in CABG. On average, PAD in CABG costs $508,000 to $909,000 per quality-adjusted year of life saved, depending on the number of units donated. Preoperative autologous blood donation is more cost-effective (as low as $518,000 per year of life saved) when targeted to younger patients undergoing CABG at centers with high transfusion rates. The cost-effectiveness of PAD is strongly dependent on estimates of posttransfusion hepatitis incidence, but less so on plausible estimates of the current risk of human immunodeficiency virus transmission. Although the actual risk of PAD is uncertain, even a small fatality risk (> 1 per 101,000 donations) associated with blood donation by patients awaiting CABG negates all life expectancy benefits of PAD. At current costs, PAD by patients awaiting CABG is not cost-effective, producing small health benefits at high societal cost. For the individual patient, the risk of donating blood before CABG may well outweigh the benefits associated with fewer allogeneic transfusions.

    View details for Web of Science ID A1994MR31800030

    View details for PubMedID 8279884

  • Blood transfusion and blood conservation: cost and utilization issues. American journal of medical quality GOODNOUGH, L. T., BODNER, M. S., Martin, J. W. 1994; 9 (4): 172-183


    Approximately 12 million red blood cell units are transfused to nearly 4 million patients annually in the United States (1). The conservation of blood has historically arisen from awareness that the inventory of this resource is limited (2), as well as the knowledge that blood transfusion carries a risk (3). Estimates of current blood transfusion risks (4-12), and the costs of transfusion complications (13-17), are summarized in Table 1. In addition, emphasis on the costs of health care has raised issues related to the costs of blood transfusion (18, 19). Finally, recent guidelines have emphasized that in the elective transfusion setting, no blood transfusion is a desirable outcome (20, 21). Furthermore, these guidelines along with consensus conference recommendations (22) have emphasized that if blood is to be transfused, autologous (the patient's own) blood is preferable to allogeneic (from an anonymous, volunteer donor) blood. Thus, the costs of blood conservation, for which an increasing array of technologic procedures and products have become available (Table 2), have also become an issue (23). The purpose of this review is to provide an overview of emerging data on the cost-effectiveness of blood and blood conservation interventions in order to help identify areas important for future investigation.

    View details for PubMedID 7819825



    Previous clinical trials have shown that the use of recombinant human erythropoietin (EPO) can facilitate autologous blood donation and reduce allogeneic blood transfusions in autologous blood donors who are anemic at first donation. However, the role of EPO therapy in nonanemic patients remains undefined. To identify this role, a randomized, controlled, multicenter dose-escalation trial was conducted in patients whose initial hematocrit was > 39 percent (0.39).EPO (150, 300, or 600 units/kg) or placebo was administered intravenously at each of six phlebotomy visits over a 3-week study period. Sixteen (14%) of 116 patients were unable to complete the treatment protocol because of adverse events (n = 11) or for personal reasons (n = 5); 2 patients (1 EPO and 1 placebo) experienced serious adverse events.In 91 evaluable patients, additional red cell production during the study period was 440 +/- 176, 621 +/- 215, 644 +/- 196, and 856 +/- 206 mL (mean +/- SD), respectively, for patients receiving placebo and EPO at 150, 300, and 600 units/kg (p < 0.05 for all EPO groups compared to placebo). However, the percentages of patients in each group who received allogeneic blood did not differ: 2 (9%) of 23 placebo patients and 6 (9%) of 68 EPO patients.It is concluded that, while EPO therapy increased preoperative red cell production, no clinical benefit could be demonstrated in autologous blood donors who were not anemic at first blood donation.

    View details for Web of Science ID A1994MQ05800016

    View details for PubMedID 8273133

  • Blood conservation and blood salvage J Int Care Med, Goodnough LT, Bodner M, Martin J 1994: 86-92
  • INDICATIONS AND GUIDELINES FOR THE USE OF HEMATOPOIETIC GROWTH-FACTORS TRANSFUSION GOODNOUGH, L. T., Anderson, K. C., Kurtz, S., Lane, T. A., Pisciotto, P. T., Sayers, M. H., Silberstein, L. E. 1993; 33 (11): 944-959

    View details for Web of Science ID A1993MM27800013

    View details for PubMedID 7505068



    After two patients received bacterially contaminated platelet transfusions, a prospective surveillance program was instituted to perform Gram staining and microbiologic culturing of platelets at the time of transfusion. In 12 months, 3141 random-donor platelet pools (prepared from 14,481 units) and 2476 single-donor apheresis units were cultured. All single-donor apheresis units were sterile, but 6 (0.19%) of the random-donor pools were found to be bacterially contaminated, with 1 unit of 5 in the pool being the source in each case. Contaminants were Staphylococcus epidermidis (4 cases), Bacillus cereus (1), and Staphylococcus aureus (1) at counts of 0.5 x 10(2) to 10(11) colony-forming units per mL in platelet pools and 10(3) to 10(13) colony-forming units per mL in source units. The contamination rate for units transfused at < or = 4 days (1.8/10,000) was significantly lower than that at 5 days (11.9/10,000; p < 0.05), as was the magnitude of contamination (p < 0.05). Use of the pretransfusion Gram stain on 4- and 5-day-old platelet pools was 100 percent sensitive (4/4 true positives) and 99.93 percent specific (1 false positive) in detecting contaminated pools. These data define the extent and magnitude of platelet bacterial contamination and demonstrate the efficacy of the pretransfusion Gram stain on platelet units stored for 4 and 5 days in preventing the transfusion of heavily contaminated units. It is concluded that the risk of platelet contamination is related to the duration of component storage.(ABSTRACT TRUNCATED AT 250 WORDS)

    View details for Web of Science ID A1993MM27800005

    View details for PubMedID 8259595



    We have analyzed the relationship between blood lost and blood transfusions given to 498 consecutive patients undergoing primary elective coronary artery bypass graft operations at 18 institutions. Seventy-nine percent of blood and 59 percent of patients were transfused only on the day of the operation. Patients who received none, 1 or 2 units of blood were not different when analyzed for blood transfusion risk factors except for the percentage of patients who were female. We identified 91 patients who received transfusion inappropriately, using a clinical indicator that analyzed blood losses for each patient. Forty-nine percent of all patients transfused could have avoided exposure to homologous blood if the equivalent of 4 units of the blood in erythrocyte volume had been provided for blood transfusion needs; if blood determined to have been transfused inappropriately had not been given, 95 percent of all patients would have received four or fewer erythrocyte units. We conclude that physician education and quality assurance programs need to be coupled with innovative blood conservation efforts that provide the equivalent of 4 units of homologous blood to minimize blood transfusions in this setting.

    View details for Web of Science ID A1993MA40400003

    View details for PubMedID 8211576


    View details for Web of Science ID A1993LM76400002

    View details for PubMedID 8328872



    Although the frequency of preoperative autologous blood donation is increasing dramatically, the economic implications of its use remain largely unexplored. Decision analysis was used to calculate the cost-effectiveness of autologous blood donation for hip and knee replacement. Cost-effectiveness, expressed as cost per quality-adjusted year of life saved, was based on observed red cell use in 629 patients undergoing surgery at two tertiary-care centers. Autologous blood donation for bilateral and revision joint replacement cost $40,000 per quality-adjusted year of life saved at Center 1 and $241,000 at Center 2. Autologous blood donation for primary unilateral hip replacement cost $373,000 per quality-adjusted year of life saved at Center 1 and $740,000 at Center 2. Autologous blood donation was least cost-effective for primary unilateral knee replacement ($1,147,000/quality-adjusted year of life saved at Center 1 and $1,467,000/year at Center 2). Differences between autologous blood collections and transfusion requirements explained variations among procedures in the cost-effectiveness of autologous blood donation. Higher transfusion rates in autologous blood donors than in nondonors accounted for the poorer cost-effectiveness of autologous blood donation at Center 2 than at Center 1. Autologous blood donation is not as cost-effective as most accepted medical practices. Its cost-effectiveness can be improved substantially by the avoidance of overcollection and overtransfusion of autologous blood.

    View details for Web of Science ID A1993LM69100004

    View details for PubMedID 8333017

  • THE NEED FOR STANDARDIZATION OF CRYOPRECIPITATE-DERIVED FIBRIN ADHESIVE TRANSFUSION SCIENCE Pisciotto, P. T., Anderson, K. C., GOODNOUGH, L. T., Kurtz, S. R., Lane, T. A., Sayers, M. H., Silberstein, L. E. 1993; 14 (3): 291-294


    In addition to historically important issues of blood inventory and blood safety, the costs of blood transfusion are anticipated to have an increasingly important impact on transfusion practices. To address this, we analyzed costs of blood support given to patients undergoing coronary artery bypass graft (CABG) surgery, along with costs of blood components whose transfusions were identified to be unnecessary.Blood components transfused as part of a previously reported national, multicenter audit of 30 adult patients each at 18 institutions undergoing primary, elective CABG surgery were reviewed.The range of blood purchase costs among institutions was broad, varying over two-fold. The range of red cell units transfused varied over 10-fold, and the range of total components transfused varied over 40-fold. The number of blood components transfused unnecessarily represented 27% of all blood units transfused, ranging from 7% to 43% among institutions. Inappropriate transfusions accounted for 47%, 32%, and 15% of all platelet, plasma, and red cell units transfused. The mean institutional cost for all blood components transfused per patient was $397 +/- $244. The cost per patient of components transfused inappropriately was 24% of this, or $96 +/- $89 (mean +/- SD).These costs could be reduced with practice guidelines and quality improvement programs aimed at reducing the number of inappropriate transfusions.

    View details for Web of Science ID A1993LC87400010

    View details for PubMedID 8498396



    Autologous blood predeposit is a widely used transfusion practice that has become a standard of care for elective orthopedic operation. Despite the support for this practice, there are limitations in the use and efficacy of autologous blood programs. This study is a prospective analysis of 385 orthopedic patients in whom a type and crossmatch were requested in which 249 patients predonated autologous blood and 136 patients did not. Preoperative anemia, blood lost and the "transfusion trigger" were evaluated for each of these patients. We conclude that the prevalence of anemia (25 percent) and rate of homologous blood exposure (25 percent) in autologous blood donors indicate a need for innovative blood conservation strategies to minimize homologous blood transfusion in this patient subgroup; the high prevalence of anemia (39 percent) and the homologous blood exposure (49 percent) in patients who did not donate autologous blood demonstrate a need for early recognition and treatment to procure autologous blood and reduce homologous blood exposure in these patients. The procurement of three to eight autologous blood units, along with the regeneration of a erythrocyte volume of 8 to 12 milliliters per kilogram, would avoid homologous blood transfusion in 95 percent of the patients in this setting.

    View details for Web of Science ID A1993KQ47800006

    View details for PubMedID 8438194

  • Blood transfusions in hip fracture patients: implications for blood conservation programs. Journal of orthopaedic trauma GOODNOUGH, L. T., Riddell, J., Verbrugge, D., Marcus, R. E. 1993; 7 (1): 47-51


    To address the potential role of innovative blood conservation interventions in nonelective surgery, we reviewed blood transfusions and blood losses during hospitalization of patients undergoing open reduction internal fixation of an intratrochanteric hip fracture. Sixty-four orthopaedic patients consecutively admitted over a 3-year interval were analyzed for transfusion needs by calculating red blood cell (RBC) volume lost during hospitalization. Overall, 39 (61%) patients received blood. We found that the "transfusion-trigger" was higher for females compared to males. Fifteen (23%) of 64 patients were identified to have been transfused with RBC volumes in excess of RBC volumes lost. The remaining 49 patients determined to be untransfused or to be transfused appropriately received 1.4 +/- 2.1 blood units (M +/- SD). Of these, 30 (60%) received < or = 1 U. We found no evidence that patients who received blood transfusions in excess of blood losses benefited compared to those whose blood replacement was less than blood lost. We conclude that innovative blood conservation interventions such as recombinant human erythropoietin (EPO) therapy can be incorporated into this nonelective surgical setting and may permit a significant percentage of hip fracture patients to avoid homologous blood transfusion. An algorithm for physician education programs that can address blood transfusion practices is provided so that patients can benefit from new blood conservation approaches.

    View details for PubMedID 8433199

  • Erythropoietin--does it increase the efficiency of autologous blood donation? Beiträge zur Infusionstherapie = Contributions to infusion therapy GOODNOUGH, L. T. 1993; 29: 240-250

    View details for PubMedID 7690657

  • Evaluating the safety and efficacy of pharmacologic alternatives to blood. Ann Thor Surg Goodnough LT 1993: 1004-1005

    View details for Web of Science ID A1993KF70200018

    View details for PubMedID 8431340

  • The role of recombinant growth factors in transfusion medicine Br J Anaesth, Goodnough LT 1993: 80-86


    To determine the impact of platelet leukodepletion by filtration on the overall prevalence of reported transfusion reactions associated with platelet concentrates, we audited platelet transfusion reactions after infusion of platelet concentrates reported at University Hospitals of Cleveland over 6 months before (interval 1, July 1, 1989 to December 31, 1989) and after (interval 2, July 1, 1990 to December 31, 1990) implementation of the Pall PL 50 filter on our adult Hematology-Oncology inpatient unit (Division 60). Thirty-two (1.7%) of 1,901 random, pooled platelet transfusion events resulted in blood bank transfusion reaction workups in interval 1, compared to 90 (5.3%) of 1,704 in interval 2 (p < 0.001). The Division 60 service accounted for more of our hospital-wide platelet reactions after implementation of the filter in interval 2 (84%) than before filtration in interval 1 (42%), p = 0.002. The prevalence of reaction workups for Division 60 was 0.6% for interval 1, compared to 4.3% for interval 2 (p < 0.001). No differences were found between interval 1 and interval 2 for the rate of discontinuation of platelet transfusion (36 vs. 32%, p = 0.14), rate of premedication for platelet transfusion (72 vs. 65%, p = 0.6), percentage of direct antiglobulin test-positive reactions (17 vs. 5.4%, p = 0.09), percentage showing icteric/hemolyzed serum (15 vs. 4.4%, p = 0.09), or reactions believed to be due to red blood cell incompatibility (8.8 vs. 1.1%, p = 0.1).(ABSTRACT TRUNCATED AT 250 WORDS)

    View details for Web of Science ID A1993LT13000004

    View details for PubMedID 8212663

  • Blood conservation and blood transfusion practices: Flip sides of the same coin. Editorial. Ann Thor Surg Goodnough LT 1993: 3-4
  • The rationale for the use of recombinant human erythropoietin to facilitate autologous blood collection before elective surgery. Contrib To Nephrol Goodnough LT 1993: 401-409


    The discharge hematocrit has been analyzed as a clinical indicator of the transfusion trigger by which to identify patients undergoing elective orthopedic surgery who were transfused with blood in excess of need. The volume of red cells lost by each patient during surgical hospitalization was compared to the volume of red cells transfused. Three clinical indicator levels were considered. Red cell losses of 10, 20, and 30 percent of each patient's baseline red cell volume at admission were considered to be appropriate before subsequent blood transfusion replacement, representing generous, intermediate, or strict clinical indicator levels, respectively. With Level I as a generous clinical indicator, 110 (25%) of 525 patients were transfused in excess of blood needs; by Level II (intermediate) and Level III (strict) criteria, 221 (42%) and 314 (60%) of 525 patients, respectively, were transfused in excess of blood needs. Significant differences were found for transfused patients analyzed by gender (26% of women vs. 13% of men; Level I, p less than 0.001) and preoperative autologous blood donation (25% of autologous blood donors vs. 11% of those who did not donate autologous blood; Level I, p less than 0.001). It can be concluded that the discharge hematocrit and amount of blood lost during hospitalization can be used as clinical indicators with which to identify patients receiving transfusions in excess of needs in the elective surgical setting. With this method, it was found that the transfusion trigger is different for women and for men as well as for autologous blood donors and those who did not donate autologous blood undergoing elective orthopedic surgery [corrected].

    View details for Web of Science ID A1992JM76100011

    View details for PubMedID 1519327



    Autologous blood predeposit is a widely used transfusion practice that has become a standard of care for elective surgery. Despite the support for this practice there are unanswered questions in the usage and efficacy of autologous blood programs. This study is a prospective analysis of 52 consecutively audited urologic patients undergoing elective, radical prostatectomy with lymphadenectomy in which all 52 patients predonated autologous blood. Preoperative blood donation, blood transfused, surgical blood lost, and the "transfusion trigger" were evaluated for each of these patients. We conclude (1) the rate of homologous blood exposure (15%) despite preoperative autologous blood donation in every patient indicates a need for innovative blood conservation strategies to minimize homologous blood transfusion in this surgical group. (2) Unnecessary autologous transfusions could be identified in 8 (15%) of 52 patients, all of which were single unit autologous blood transfusions. (3) Physician education programs that emphasize increased procurement of autologous blood along with more conservative transfusion of this blood are needed to avoid necessary homologous blood and unnecessary autologous blood transfusion.

    View details for Web of Science ID A1992JP24000002

    View details for PubMedID 1523740

  • LEUKOCYTE REDUCTION IN BLOOD COMPONENT THERAPY ANNALS OF INTERNAL MEDICINE Lane, T. A., Anderson, K. C., GOODNOUGH, L. T., Kurtz, S., MOROFF, G., Pisciotto, P. T., Sayers, M., Silberstein, L. E. 1992; 117 (2): 151-162


    To review methods of preventing or minimizing the adverse effects associated with the transfusion of passenger leukocytes present in cellular blood components and to define groups of patients who are at risk for adverse effects.English-language articles on transfusion medicine.Original reports describing the pathogenesis of leukocyte-induced adverse effects in transfusion recipients and the influence of leukocyte-reduced blood components on these effects.Evaluation of the diagnosis, transfusion history, and treatment of the study patients; the methods and results of leukocyte reduction; and specific outcomes, including development of alloimmunization to leukocytes, febrile reactions to transfusion, and platelet refractoriness.Passenger leukocytes are the chief cause of alloimmunization to human leukocyte antigen (HLA) and leukocyte-specific antigens in transfusion recipients. Alloimmunization may result in febrile transfusion reactions, platelet refractoriness, and acute lung injury. Leukocytes are also the vector for transfusion-associated cytomegalovirus infection. Technologic advances in the leukocyte reduction of cellular blood components have made it possible to reduce the number of leukocytes to fewer than 10(7) per transfusion. Findings suggest that the use of leukocyte-reduced cellular blood components may minimize or prevent recurrent febrile reactions and alloimmunization to leukocyte antigens. Cytomegalovirus may not be transmitted by blood components containing fewer than 10(7) leukocytes.Leukocyte reduction in red blood cell and platelet transfusions using third-generation filters is indicated for selected patients who are likely to receive long-term transfusion support, to prevent recurrent febrile reactions and to prevent or delay alloimmunization to leukocyte antigens. Leukocyte-depleted transfusions may also be indicated to delay or prevent refractoriness to platelet transfusion.

    View details for Web of Science ID A1992JD12300010

    View details for PubMedID 1605430



    To determine the potential impact of recombinant human erythropoietin (EPO) therapy in patients undergoing autologous bone marrow transplantation (BMT) and colony-stimulating factor therapy, we assayed endogenous serum EPO levels and noted blood transfusion requirements in relapsed non-Hodgkin's lymphoma patients treated with high-dose chemo-radiation therapy and autologous BMT. Hematocrit and reticulocyte counts were determined daily, and hematocrit was maintained in the 25-30% range by transfusion according to criteria established by our hospital transfusion committee. EPO levels were measured by radioimmunoassay and were determined at baseline, throughout therapy, and 2 and 3 months after BMT. Serum EPO levels increased more than 25-fold above baseline in most subjects after initiating chemoradiation therapy. No correlation was noted between serum EPO and hematocrit, reticulocyte count or serum creatinine. Total red blood cell units transfused ranged from 4 to 15 (mean 7.7). Mean total donor exposures (red blood cell plus platelet units transfused) were 83.6 units (range 16-175). Serum EPO levels increased early in the course of preparation for autologous BMT and remained elevated for at least 2-3 weeks thereafter although at a lower level. Red blood cell transfusions were required despite very high EPO levels after BMT. Red cell transfusions, moreover, accounted for only 9.2% (69 of 746) of total donor exposures and only 5.8% (42 of 746) of donor exposures during the interval when pharmacologic doses of erythropoietin might be of benefit. In contrast to the potential benefit of colony-stimulating factors such as G-CSF and GM-CSF in BMT, our study suggests limited value for erythropoietin therapy in this setting.

    View details for Web of Science ID A1992JJ60200011

    View details for PubMedID 1515882



    Previous studies have demonstrated that autologous blood donors have a suboptimal endogenous erythropoietin response to the mild anemia induced by blood donation. Recent studies in baboons subjected to aggressive phlebotomy have shown an acceleration of erythropoiesis that may be beneficial perioperatively. To address the issue of accelerated erythropoiesis in autologous blood donors, red cell production during an aggressive preoperative autologous blood donation program was analyzed. The volume of red cells increased 568 mL (27% over baseline) and 911 mL (47% over baseline) for 23 placebo and 21 erythropoietin-treated patients, respectively, by hospital admission (9 days after last drug administration and 26 days after beginning therapy). The mean rate of additional red cell production was 22 mL per day in the placebo group and 34 mL per day in the erythropoietin group (p less than 0.001), which represents a twofold and a 2.5-fold increase over basal erythropoiesis, respectively. The major difference in red cell production in the placebo and erythropoietin groups occurred early in the collection period. It can be concluded that an aggressive autologous blood phlebotomy program results in clinically important increased erythropoiesis at the time of surgery. In patients unsuited for aggressive autologous phlebotomy, a more modest autologous blood procurement program, coupled with the administration of recombinant erythropoietin, may be a preferable approach.

    View details for Web of Science ID A1992JB60600011

    View details for PubMedID 1626347



    To determine whether combination chemotherapy is superior to single agents for recurrent/metastatic head and neck cancer, we compared the efficacy and toxicity of cisplatin (CP) and fluorouracil (5-FU), alone and in combination in a phase III trial.Two hundred forty-nine patients with recurrent head and neck cancer were randomized to one of three treatments: CP (100 mg/m2) and 5-FU (1 g/m2 x 4), CP, or 5-FU every 3 weeks.The overall response rate to the combination (32%) was superior to that of CP (17%) or 5-FU (13%) (P = .035). Response was associated with good performance status (PS) but not with primary site, site of recurrence, histology, prior irradiation, or relative dose intensity. Median time to progression was less than 2.5 months, and there was no significant difference in median survival (5.7 months) among the groups. By multivariate analysis, patients with better PS and poorly differentiated tumors had superior survival. Hematologic toxicity and alopecia were worse in the combination arm.Although the response rate to the combination of CP plus 5-FU was superior to that achieved with single agents, survival did not improve.

    View details for Web of Science ID A1992HB27000011

    View details for PubMedID 1732427

  • Prevalence and correlates of hospital-based autologous blood programs: a statewide survey. Am J Med Sci. Hull AL, Neuhauser DV, Goodnough LT 1992; May;303 (5): 285-8
  • Prudent strategies for elective red blood cell transfusion. Ann Intern Med. Welch HG, Meehan KR, Goodnough LT. 1992; Mar 1;116 (5): 393-402
  • Teaching medical students concepts of informed consent within the framework of a transfusion medicine curriculum. Acad Med. Goodnough LT, Hull AL, Kleinhenz ME 1992; May;67 (5): 348
  • Nonhemic prime in cardiopulmonary bypass. (reply to Letter). Ann Thor Surg Geha AS, Goodnough LT 1992: 180
  • Toward bloodless surgery: erythropoietin therapy in the surgical setting. Semin Oncol. Goodnough LT 1992; Jun;19 (3 Suppl 8): 19-24
  • Designated blood requests in elective surgery (letter). Am J Surg Goodnough LT, Schuck JM 1992: 366-367
  • Autologous blood donation in nonorthopaedic surgical procedures as a blood conservation strategy. Vox Sang. Goodnough LT, Saha P, Hirschler NV, Yomtovian R. 1992; 63 (2): 96-101
  • Strategies for elective red cell transfusion (reply to letter). Ann Int Med Goodnough LT, Welch HG, Audet AM 1992: 442
  • Erythropoietin therapy as a surgical blood conservation intervention. Laboratory Medicine Goodnough LT 1992: 457-460
  • Toward bloodless surgery: Erythropoietin in the surgical setting. Seminars In Oncol Goodnough LT 1992: 19-24
  • Prevalence and classification of anemia in elective orthopedic surgery patients: implications for blood conservation programs. Vox Sang. Goodnough LT, Vizmeg K, Sobecks R, Schwarz A, Soegiarso W. 1992; 63 (2): 90-5
  • Reducing the risk for transfusion-transmitted cytomegalovirus infection. Ann Intern Med. Sayers MH, Anderson KC, Goodnough LT, Kurtz SR, Lane TA, Pisciotto P, Silberstein LE. 1992; Jan 1;116 (1): 55-62
  • Effect of autologous blood donation in patients undergoing elective spine surgery. Spine (Phila Pa 1976). Goodnough LT, Marcus RE 1992; Feb;17 (2): 172-5
  • Variation in blood component irradiation practice: implications for prevention of transfusion-associated graft-versus-host disease. Blood. Anderson KC, Goodnough LT, Sayers M, Pisciotto PT, Kurtz SR, Lane TA, Anderson CS, Silberstein LE 1991; May 15;77 (10): 2096 - 102
  • Selective in vivo removal of rheumatoid factor by an extracorporeal treatment device in rheumatoid arthritis patients. Transfusion Lazarus HM, Cohen SB, Clegg DO, Menitove JE, Sorin SB, Hinkle S, Markenson JA, Saal S, Goodnough LT, Fleischmann RM. 1991; Feb; 31 (2): 122-8
  • The variability of transfusion practice in coronary artery bypass surgery. Transfusion Medicine Academic Award Group. JAMA. Goodnough LT, Johnston MF, Toy PT 1991; Jan 2;265 (1): 86-90
  • Iron-restricted erythropoiesis as a limitation to autologous blood donation in the erythropoietin-stimulated bone marrow. J Lab Clin Med. Goodnough LT, Price TH, Rudnick S 1991; Sep;118 (3): 289-96
  • A new era in blood conservation (editorial) Ann Thor Surg Goodnough LT, Geha AS 1991: 703-704
  • Blood transfusion in elective orthopaedic surgery: Issues related to informed consent. Perspectives in Orthopaedics Goodnough LT, Marcus RE 1991: 104-118
  • Autologous blood donation as a medical insurance policy (Letter) Cont Obstet Gynec Goodnough LT 1990: 127
  • Guidelines for transfusion support in patients undergoing coronary artery bypass grafting. Transfusion Practices Committee of the American Association of Blood Banks. Ann Thorac Surg. Goodnough LT, Johnston MF, Ramsey G, Sayers MH, Eisenstadt RS, Anderson KC, Rutman RC, Silberstein LE 1990; Oct; 50 (4): 675-83
  • Identifying personnel to receive continuing medical education about appropriate use of blood transfusions. Acad Med. Goodnough LT, Hull AL, Brennan PF, Shah VA, Martin B 1990; Oct; 65 (10): 661
  • Erythropoietin as a pharmacologic alternative to blood transfusion in the surgical patient. Transfus Med Rev. Goodnough LT 1990; Oct; 4 (4): 288-96
  • Erythropoietin as a pharmacologic alternative to homologous blood transfusion in the surgical patient Transfusion Medicine Reviews Goodnough LT 1990: 288-296
  • Recombinant human erythropoietin therapy in autologous blood donors Progress In Clinical and Biological Research Goodnough LT 1990: 105-112
  • Potential role of recombinant human erythropoietin in the peri-surgical setting. Int J Cell Cloning. Goodnough LT 1990; Jan;8 (Suppl 1): 203-10
  • "Homologous blood transfusion needs in elective orthopaedic surgery: Potential role of erythropoietin therapy. (Letter) N Engl J Med Goodnough LT, Marcus RE 1990: 1158-1159
  • Utilization and effectiveness of autologous blood donation for arthroplastic surgery. Arthroplasty. 1990;5 Suppl:S89-94. Goodnough LT, Shafron D, Marcus RE. 1990: Suppl: S89-94
  • Limitations of the erythropoietic response to serial phlebotomy: implications for autologous blood donor programs. J Lab Clin Med. Goodnough LT, Brittenham GM. 1990; Jan;115 (1): 28-35
  • The impact of preoperative autologous blood donation on orthopaedic surgical practice. Vox Sang. Goodnough LT, Shafron D, Marcus RE. 1990; 59 (2): 65-9
  • Erythropoietin therapy in autologous blood donors. Prog Clin Biol Res. Goodnough LT. 1990: 105-12
  • Risks, options, and informed consent for blood transfusion in elective surgery. Am J Surg. Review. Goodnough LT, Shuck JM. 1990; Jun;159 (6): 602-9
  • Directed blood procurement does not benefit patients who are enrolled in an autologous blood predeposit program. Am J Clin Pathol. Goodnough LT 1989; Oct; 92 (4): 484-7
  • Red blood cell mass in autologous and homologous blood units. Implications for risk/benefit assessment of autologous blood crossover and directed blood transfusion. Transfusion. Goodnough LT, Bravo JR, Hsueh YS, Keating LJ, Brittenham GM 1989; Nov-Dec;29 (9): 821-2
  • Effects of a CME program on physicians' transfusion practices. Acad Med. Hull AL, Wasman J, Goodnough LT. 1989; Nov; 64 (11): 681-5
  • A two-institution study of transfusion practice in 78 consecutive adult elective open-heart procedures. Am J Clin Pathol. Goodnough LT, Johnston MF, Shah T, Chernosky A. 1989; Apr; 91 (4): 468-72
  • Increased preoperative collection of autologous blood with recombinant human erythropoietin therapy. N Engl J Med. Goodnough LT, Rudnick S, Price TH, Ballas SK, Collins ML, Crowley JP, Kosmin M, Kruskall MS, Lenes BA, Menitove JE, et al. 1989; Oct 26;321 (17): 1163-8
  • Limitations to donating adequate autologous blood prior to elective orthopedic surgery. Arch Surg. Goodnough LT, Wasman J, Corlucci K, Chernosky A. 1989; Apr; 124 (4): 494-6
  • The bleeding severity index: validation and comparison to other methods for classifying bleeding complications of medical therapy. J Clin Epidemiol. Landefeld CS, Anderson PA, Goodnough LT, Moir TW, Hom DL, Rosenblatt MW, Goldman L. 1989; 42 (8): 711-8
  • Thrombogenic toxicity of breast cancer treatment: Chemotherapy versus antineoplastic effect. (Letter) N Engl J Med Goodnough LT, Pearson O 1988: 443
  • Autologous blood donation. (Letter) JAMA Goodnough LT 1988: 2404-2405
  • Preleukemia in Fanconi's anemia: hematopoietic cell multinuclearity, membrane duplication, and dysgranulogenesis. J Submicrosc Cytol. Barton JC, Parmley RT, Carroll AJ, Huang ST, Goodnough LT, Findley HW Jr, Ragab AH. 1987; Apr; 19 (2): 355-64
  • Predeposited autologous blood for elective surgery. A national multicenter study. N Engl J Med. Toy PT, Strauss RG, Stehling LC, Sears R, Price TH, Rossi EC, Collins ML, Crowley JP, Eisenstaedt RS, Goodnough LT, et al. 1987; Feb 26;316 (9): 517-20
  • Autologous blood donation for elective surgery. Effect on physician transfusion behavior. JAMA. Wasman J, Goodnough LT 1987; Dec 4;258 (21): 3135-7
  • Reptilase time for ANLL with DIC. (letter) Sca nd J Haematol Spitzer T, Rosenzweig SE, Goodnough LT, Lazarus HM, Herzig RH 1986: 411-12
  • Histidine-rich glycoprotein and changes in the components of the fibrinolytic system after streptokinase therapy in patients with pulmonary thromboembolism. Am J Hematol. Goodnough LT, Saito H, Bell WR, Heimburger N. 1985; Jul; 19 (3): 245-53
  • Bovine aortic endothelial cells elaborate an inhibitor of the generation of lipopolysaccharide-stimulated human blood monocyte procoagulant activity. J Clin Invest. Goodnough LT, Kleinhenz ME, Goldsmith GH Jr, Ziats NP, Robertson AL Jr. 1984; Jul;74 (1): 75-81
  • Increased incidence of thromboembolism in stage IV breast cancer patients treated with a five-drug chemotherapy regimen. A study of 159 patients. Cancer. Goodnough LT, Saito H, Manni A, Jones PK, Pearson OH. 1984; Oct 1; 54 (7): 1264-8
  • Thrombosis or myocardial infarction in congenital clotting factor abnormalities and chronic thrombocytopenias: a report of 21 patients and a review of 50 previously reported cases. Medicine (Baltimore). Goodnough LT, Saito H, Ratnoff OD 1983; Jul; 62 (4): 248-55
  • Synthesis and release of Hageman factor (Factor XII) by the isolated perfused rat liver. J Clin Invest. Saito H, Hamilton SM, Tavill AS, Goodnough LT, Louis L, Angell A 1983; Sep;72 (3): 948-54
  • Fibronectin levels in congenital thrombocytopenia: Schulman's syndrome. (letter) N Engl J Med Goodnough LT, Saito H, Ratnoff OD 1982: 938-939
  • Specific binding of thrombin by human peripheral blood monocytes: possible role in the clearance of activated clotting factors from the circulation. J Lab Clin Med. Goodnough LT, Saito H 1982; Jun;99 (6): 87384
  • Synthesis and secretion of alpha 2-plasmin inhibitor by established human liver cell lines. Proc Natl Acad Sci U S A. Saito H, Goodnough LT, Knowles BB, Aden DP. 1982; Sep; 79 (18): 5684-7
  • Reduced histidine-rich glycoprotein levels in plasma of patients with advanced liver cirrhosis. Possible implications for enhanced fibrinolysis. Am J Med. Saito H, Goodnough LT, Boyle JM, Heimburger N. 1982; Aug; 73 (2): 179-82
  • Urinary excretion of Hageman factor (factor XII) and the presence of nonfunctional Hageman factor in the nephrotic syndrome. Am J Med. Saito H, Goodnough LT, Makker SP, Kallen RJ. 1981; 70 (3): 531-4.
  • Heterogeneity of human prekallikrein deficiency (Fletcher trait): evidence that five of 18 cases are positive for cross-reacting material. N Engl J Med. Saito H, Goodnough LT, Soria J, Soria C, Aznar J, España F. 1981; Oct 15;305 (16): 910-4
  • Bullous pemphigoid as a manifestation of chronic lymphocytic leukemia. Arch Intern Med. Goodnough LT, Muir WA 1980; 140 (11): 1526-7

Conference Proceedings

  • Hemoglobinuria and Mechanical Hemolysis Associated with Red Blood Cell Transfusion in Pediatric Patients McNaughton, J., Hughes, J., Andrews, J. C., George, T. I., Bergero, C., Pike-Grimm, K., Galel, S., Gonzalez, C., Goodnough, L., Fontaine, M. J. AMER SOC HEMATOLOGY. 2012
  • Automated Screen for High Titer Anti-A and Anti-B and Selective Plasma Volume Reduction as an Inventory Management Strategy of ABO Plasma Incompatible Platelets Fontaine, M., Webster, J., GOODNOUGH, L. T., Galel, S. A. WILEY-BLACKWELL. 2012: 68A-68A
  • Management approaches to platelet-related microvascular bleeding in cardiothoracic surgery Despotis, G. J., GOODNOUGH, L. T. ELSEVIER SCIENCE INC. 2000: S20-S32


    Patients undergoing cardiac surgery with cardiopulmonary bypass are at increased risk for microvascular bleeding that requires perioperative transfusion of blood components. Platelet-related defects have been shown to be the most important hemostatic abnormality in this setting. The exact association between preoperative use of potent platelet inhibitors and either bleeding or transfusion in patients undergoing cardiac surgical procedures is currently being defined. Laboratory evaluation of platelets and coagulation factors can facilitate the optimal administration of pharmacologic and transfusion-based therapy. However, their turnaround time makes laboratory-based methods impractical for concurrent management of surgical patients, which has led many investigators to study the role of point-of-care coagulation tests in this setting. Use of point-of-care tests of hemostatic function can optimize the management of excessive bleeding and reduce transfusion. Accordingly, point-of-care tests that assess platelet function may also identify patients at risk for acquired, platelet-related bleeding. The ability to reduce the unnecessary use of blood products and to decrease operative time or reexploration rates has important consequences for blood inventory, blood costs, and overall health care costs.

    View details for Web of Science ID 000088934700005

    View details for PubMedID 10966007

  • Blood substitutes: evolution and future applications Scott, M. G., Kucik, D. F., GOODNOUGH, L. T., Monk, T. G. AMER ASSOC CLINICAL CHEMISTRY. 1997: 1724-1731


    The development of oxygen-carrying blood substitutes has progressed significantly in the last decade with phase I and phase II clinical trials of both hemoglobin-based and perfluorocarbon-based oxygen carriers nearing completion. As these products approach clinical use it is important for the laboratory medicine community to be aware of their effects on routine laboratory testing and the settings in which they might be used. Here we review the forces driving the development of oxygen-carrying blood substitutes, the clinical settings in which they might be used, the major categories of oxygen carriers in clinical trials, and the challenges faced by these products as they approach clinical use.

    View details for Web of Science ID A1997XV89700037

    View details for PubMedID 9299967

  • Monitoring of hemostasis in cardiac surgical patients: impact of point-of-care testing on blood loss and transfusion outcomes Despotis, G. J., Joist, J. H., GOODNOUGH, L. T. AMER ASSOC CLINICAL CHEMISTRY. 1997: 1684-1696


    Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) are at increased risk for excessive perioperative blood loss requiring transfusion of blood products. Strategies to optimize administration of heparin and protamine and the assessment of their effects on coagulation are evolving in cardiac surgical patients. Two recent evaluations have focused on the use of multiple point-of-care (POC) coagulation assays for patient-specific adjustment of heparin and protamine dosage. These studies indicate that blood loss and transfusion requirements in cardiac surgical patients may be reduced with more accurate control of heparin anticoagulation and its reversal. Blood component administration in patients with excessive post-CPB bleeding is generally empiric in part, related to turnaround times of laboratory-based tests. Methods are now available for rapid, POC assessment of coagulation to allow appropriate, targeted therapy for acquired hemostatic abnormalities. Recent studies indicate that a rapid evaluation of thrombocytopenia and coagulation factor deficiencies with POC tests can facilitate the optimal administration of pharmacologic and transfusion-based therapy in patients who exhibit excessive bleeding after CPB. POC tests that assess platelet function have been developed, and their use may facilitate identification of which patients at risk for excessive blood loss may respond to pharmacologic interventions such as desmopressin acetate or antifibrinolytic agents.

    View details for Web of Science ID A1997XV89700031

    View details for PubMedID 9299961

  • Effect of hemoglobin- and Perflubron-based oxygen carriers on common clinical laboratory tests Ma, Z. M., Monk, T. G., GOODNOUGH, L. T., McClellan, A., Gawryl, M., Clark, T., MOREIRA, P., Keipert, P. E., Scott, M. G. AMER ASSOC CLINICAL CHEMISTRY. 1997: 1732-1737


    Polymerized hemoglobin solutions (Hb-based oxygen carriers; HBOCs) and a second-generation perfluorocarbon (PFC) emulsion (Perflubron) are in clinical trials as temporary oxygen carriers ("blood substitutes"). Plasma and serum samples from patients receiving HBOCs look markedly red, whereas those from patients receiving PFC appear to be lipemic. Because hemolysis and lipemia are well-known interferents in many assays, we examined the effects of these substances on clinical chemistry, immunoassay, therapeutic drug, and coagulation tests. HBOC concentrations up to 50 g/L caused essentially no interference for Na, K, Cl, urea, total CO2, P, uric acid, Mg, creatinine, and glucose values determined by the Hitachi 747 or Vitros 750 analyzers (or both) or for immunoassays of lidocaine, N-acetylprocainamide, procainamide, digoxin, phenytoin, quinidine, or theophylline performed on the Abbott AxSym or TDx. Gentamycin and vancomycin assays on the AxSym exhibited a significant positive and negative interference, respectively. Immunoassays for TSH on the Abbott IMx and for troponin I on the Dade Stratus were unaffected by HBOC at this concentration. Tests for total protein, albumin, LDH, AST, ALT, GGT, amylase, lipase, and cholesterol were significantly affected to various extents at different HBOC concentrations on the Hitachi 747 and Vitros 750. The CK-MB assay on the Stratus exhibited a negative interference at 5 g/L HBOC. HBOC interference in coagulation tests was method-dependent-fibrometer-based methods on the BBL Fibro System were free from interference, but optical-based methods on the MLA 1000C exhibited interferences at 20 g/L HBOC. A 1:20 dilution of the PFC-based oxygen carrier (600 g/L) caused no interference on any of these chemistry or immunoassay tests except for amylase and ammonia on the Vitros 750 and plasma iron on the Hitachi 747.

    View details for Web of Science ID A1997XV89700038

    View details for PubMedID 9299968


    View details for Web of Science ID A1994PB88500039

    View details for PubMedID 7975489

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