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Serious hazards of transfusion (SHOT) initiative: analysis of the first two annual reports.

OBJECTIVE: To receive and collate reports of death or major complications of transfusion of blood or components. DESIGN: Haematologists were invited confidentially to report deaths and major complications after blood transfusion during October 1996 to September 1998. SETTING: Hospitals in United Kingdom and Ireland. SUBJECTS: Patients who died or experienced serious complications, as defined below, associated with transfusion of red cells, platelets, fresh frozen plasma, or cryoprecipitate. MAIN OUTCOME MEASURES: Death, "wrong" blood transfused to patient, acute and delayed transfusion reactions, transfusion related acute lung injury, transfusion associated graft versus host disease, post-transfusion purpura, and infection transmitted by transfusion. Circumstances relating to these cases and relative frequency of complications. RESULTS: Over 24 months, 366 cases were reported, of which 191 (52%) were "wrong blood to patient" episodes. Analysis of these revealed multiple errors of identification, often beginning when blood was collected from the blood bank. There were 22 deaths from all causes, including three from ABO incompatibility. There were 12 infections: four bacterial (one fatal), seven viral, and one fatal case of malaria. During the second 12 months, 164/424 hospitals (39%) submitted a "nil to report" return. CONCLUSIONS: Transfusion is now extremely safe, but vigilance is needed to ensure correct identification of blood and patient. Staff education should include awareness of ABO incompatibility and bacterial contamination as causes of life threatening reactions to blood.

Blood Component Transfusion↗

A randomized trial of tranexamic acid in combination with cell salvage plus a meta-analysis of randomized trials evaluating tranexamic acid in off-pump coronary artery bypass grafting.

OBJECTIVES: We sought to evaluate the effectiveness of tranexamic acid in off-pump coronary artery bypass grafting surgery, either when used in combination with mechanical cell salvage or when used alone. METHODS: One hundred patients were randomized to either 2 g of tranexamic acid as an intravenous bolus before sternotomy or to placebo. Intraoperative and postoperative cell salvage was used in all patients. The primary end point was early postoperative blood loss (within 4 hours). To evaluate the efficacy of tranexamic acid in isolation, we also performed a meta-analysis of 4 randomized trials identified from a systematic literature search. The primary end point of the meta-analysis was red cell transfusion. RESULTS: In our randomized trial patients in the tranexamic acid group had a significant reduction in early postoperative blood loss, (median difference, 50 mL; 95% confidence interval, 15-100 mL; P < .01); however, there was no reduction in the frequency of blood component transfusion. Patients in the placebo group received a significantly larger volume of autotransfused red cells (median difference, 120 mL; 95% confidence interval, 0-220 mL; P = .02). The meta-analysis demonstrated a significant reduction in red cell transfusions in patients receiving tranexamic acid compared with those receiving placebo (risk ratio, 0.48; 95% confidence interval, 0.24-0.97; P = .041). There was also a reduction in the frequency of any allogeneic blood component transfusion, as well as a highly significant reduction in postoperative blood loss, in patients receiving tranexamic acid (P < .001). CONCLUSIONS: Tranexamic acid reduces blood loss and transfusion requirements in off-pump coronary artery bypass grafting surgery. A reduction in allogeneic blood transfusion was not evident in the presence of perioperative cell salvage. These data support the routine use of tranexamic acid in off-pump coronary artery bypass grafting surgery.

Adult↗

Characterization of reactions after transfusion of cellular blood components that are white cell reduced before storage.

BACKGROUND: During the storage of cellular components before transfusion, cytokines that may mediate transfusion reactions are released from white cells (WBCs). Adverse effects of transfused cellular blood components therefore depend not only on the number of residual WBCs in blood components, but also on the timing of WBC reduction. STUDY DESIGN AND METHODS: Febrile nonhemolytic transfusion reactions (FNHTRs), allergic reactions, and other reactions were characterized in recipients of 4728 units of red cells (RBCs) and 3405 bags of single-donor apheresis platelets (SDAPs), all of which underwent prestorage WBC reduction. To delineate the impact of prestorage versus poststorage WBC reduction of RBCs on transfusion reactions, these results were compared with reactions occurring after the transfusion to similar recipients of 6447 bags of RBCs that underwent poststorage WBC reduction by bedside filtration and 5197 units of SDAPs that underwent prestorage WBC reduction. The levels of interleukin (IL) 1 beta, IL-6, IL-8, and tumor necrosis factor-alpha (TNF-alpha) were measured in a subset of 20 implicated cellular blood components at the time of transfusion reactions and correlated with the duration of storage before transfusion. RESULTS: The incidence of reactions was greater after transfusions of SDAPs (5.49%) than of RBCs (1.63%). The incidence of FNHTRs after transfusion of RBCs that were WBC reduced before storage (1.1%) was significantly lower (p = 0.0045) than that after transfusion of RBCs that were WBC reduced after storage (2.15%). Although allergic reactions to RBCs that were WBC reduced before storage were also less common (0.41%) than those to RBCs that were WBC reduced after storage (0.51%), the difference was not significant (p = 0.067). At the time of reactions to RBCs and SDAPs that were reduced before storage, the level of IL-6 was negatively correlated (r = -0.54, p = 0.014) with the duration of storage before transfusion, and there was no correlation between the level of either IL-1 beta or IL-8 and the interval before transfusion. TNF-alpha was not detectable in any implicated component. CONCLUSION: FNHTRs, but not allergic reactions, were less common after transfusion of RBCs that were WBC reduced before storage than after the transfusion of those WBC reduced after storage at the bedside by filtration. The level of IL-6 in implicated cellular blood components that were WBC reduced before storage was inversely correlated with the length of storage before transfusion. Further studies are needed to determine whether the transfusion of cellular blood components that were WBC reduced before storage can both diminish the incidence of adverse reactions and improve outcome.

Blood Component Removal↗

Risks associated with transfusion of cellular blood components in Canada.

We provide a comprehensive review of risks associated with allogeneic red blood cell and platelet transfusions in Canada. The review focuses on clinically symptomatic noninfectious transfusion risks (acute and delayed hemolytic, febrile nonhemolytic [FNHTR], allergic, volume overload, transfusion-related acute lung injury, graft-versus-host disease, and posttransfusion purpura) and the risk of clinically significant disease from transfusion-transmitted infections. Data sources include information from Canadian Blood Services, Héma-Québec, Health Canada, and the Québec Hemovigilance System as well as published information from research studies and international hemovigilance systems. We estimate that in 2000 the aggregate risk of potentially severe reactions (excluding FNHTR and minor allergic reactions) was 43.2 per 100000 red cell units (95% confidence interval [CI]: 38.7-48.1), affecting 337 recipients, and 125.7 per 100000 platelet pools of 5 units (95% CI: 100.8-154.9), affecting 88 recipients. The most frequent potentially severe outcomes for red cell transfusion were hemolytic reactions and volume overload and for platelet transfusion were major allergic reactions and bacterial contamination. The current risk of human immunodeficiency virus and hepatitis C virus transmission is approximately 1 in 4 million and 1 in 3 million units, respectively. These estimates are useful for decisions concerning transfusion therapy, the informed consent process, and for evaluating efficacy of interventions to reduce risk.

Blood Component Transfusion↗

Collection and transfusion of blood and blood components in the United States, 1994.

BACKGROUND: Collections and transfusions of blood in the United States in 1994 were measured and compared with those in 1992. STUDY DESIGN AND METHODS: Completed survey questionnaires were returned by all 147 regional blood centers, 1340 American Association of Blood Banks (AABB) member hospitals, and 523 non-AABB hospitals. Statistical tests verified the representativeness of the sample. RESULTS: The United States domestic blood supply in 1994 (13,340,000 units) was 3.3 percent less than in 1992. It included allogeneic blood (11,773,000 units), autologous blood (1,013,000 units), and directed donations (334,000 units). Of these, 432,000 units were rejected on testing, 11,107,000 units were transfused to 3,398,000 patients, and 1,801,000 units were discarded or unaccounted for. Platelet transfusions amounted to 7,866,000 units. Compared with the totals for 1992, transfusions of single-donor platelets (714,000 packs or 4,284,000 units) increased by 17.6 percent, while transfusions of platelet concentrates (3,582,000 units) fell by 23.6 percent. Fresh-frozen plasma transfusions (2,621,000 units) increased by 16.2 percent over the number for 1992. CONCLUSIONS: The US blood collection rate in 1994 was 74.6 units per 1000 population of donor age, the lowest recorded level since 1971. The US RBC transfusion rate in 1994 was 42.8 units per 1000 population, about the same as 1979. Transfusions of single-donor platelets, 16.5 units per 1000 population, exceeded transfusions of platelet concentrate (13.8/1000) for the first time. Plasma transfusions were 10.1 units per 1000 population. The US blood supply in 1994 was adequate to meet patient demands.

Blood Banks↗

[Leucocyte removal and its clinical application].

Blood transfusion leads to leucocyte-mediated adverse reactions related to the transfusion of leucocytes in allogeneic blood and blood products. The leucocytes are also capable of transmitting virus infection. Leucocyte depletion of homologous blood products can effectively reduce the immunosuppressive effect as well as minimize the likelihood of transmitting virus. Blood component transfusion is generally "buffy-coat-poor", which removes about two thirds of the leucocytes present in whole blood. Using special filters, blood component can be filtrated 99.9% of the leucocytes. Leucocyte-depletion using filter should significantly lessen the leucocyte-mediated transfusion adverse reactions, such as febrile non-hemolytic transfusion reactions and graft versus host disease. At the same time, leucocyte filtration can decrease the risk of transmitting virus. Otherwise, leucocyte-depletion plays very important role in the treatment of cardiac surgical patients to attenuate leukocyte-mediated inflammation and organ reperfusion injury, the treatment of ulcerative colitis, and the treatment intractable diseases such as autoimmune and neurologic diseases.

Blood Component Removal↗

Novel processes for inactivation of leukocytes to prevent transfusion-associated graft-versus-host disease.

Transfusion-associated graft-versus-host disease (TA-GVHD) is a serious complication of blood component transfusion therapy. Currently, cellular blood components for patients recognized at risk for TA-GVHD are irradiated prior to transfusion in order to prevent this complication. Considerable progress has been made in elucidating the pathophysiology of this highly morbid complication, but questions as to which patients are at risk and what is the most robust technology to prevent TA-GVHD remain. As new technologies for inactivating or modulating leukocyte function are introduced, the question of how to evaluate these technologies becomes relevant. Over the past two decades, a number of research groups have explored technology to inactivate infectious pathogens and leukocytes contaminating cellular blood components. Few clinicians have an in-depth understanding of the methods or the criteria for selection of how to approach new technologies for leukocyte inactivation with potential to replace current methods. This mini review focuses on the salient aspects of current and evolving technology for prevention of TA-GVHD.

Graft vs Host Disease↗

Evidence of hepatitis in patients receiving transfusions of blood components containing antibody to hepatitis C.

When hepatitis C virus antibody (anti-HCV) enzyme immunoassay (EIA1) testing became available in 1990, we tested samples from previously transfused blood units, traced the recipients of reactive units, and evaluated the recipients for HCV infection during the 12 months after transfusion. Ten of 42 recipients of EIA1-reactive blood were anti-HCV reactive on follow-up by EIA1 and 12 were reactive by a second-generation assay (EIA2). Reverse transcriptase-polymerase chain reaction (RT-PCR) detected HCV RNA in 5 seronegative recipients. In all, 17 of 42 recipients (40%) of EIA1-reactive blood had evidence of HCV infection. In comparison, 54 surgery patients, who received either no transfusion or autologous EIA1-nonreactive blood, remained EIA1 nonreactive and RT-PCR negative for 1 year; 1 patient (1.8%) became EIA2 reactive (P < or = .01). Of the recipients of anti-HVC reactive blood transfusions (reactive by both EIA1 and a supplemental 4-antigen strip immunoblot assay [RIBA2]), 14 (93%) of the recipients had evidence of HCV infection compared with only 3 of 27 recipients (11%) of EIA1-reactive, RIBA2-nonreactive blood (P < or = .01). Thus, blood components reactive for anti-HCV EIA1 may have transmitted HCV up to 40% of the time, but blood components found reactive by both EIA1 and RIBA2 may transmit HCV with a frequency of greater than 90%.

Adult↗

The effect of an intraoperative treatment algorithm on physicians' transfusion practice in cardiac surgery.

BACKGROUND: 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. STUDY DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSION: The use of algorithms by transfusion decision makers can serve as an effective physician education intervention.

Adult↗

Reducing the risk of bacterial contamination of cellular blood components.

Transfusion-associated septic reactions occurring during or following the transfusion of cellular blood components was one of the earliest recognised complications of allogeneic blood transfusions. The presence of bacteria in cellular blood products thus has been a problem for many decades and currently it is the most common microbiological cause of transfusion-associated morbidity and mortality. Transfusion-associated septic reactions due to contaminated platelet concentrates appear to be much more common than those due to red cell concentrates. The prevalence of contaminated cellular blood products (red cells and platelets) is approximately 1 in 2,000. However, the transfusion to a recipient of a contaminated blood product may not be associated with morbidity, because many contaminated blood product units contain only few bacteria and such transfusions may be innocuous to the recipient. In other instances, contaminated blood product units may contain large numbers of virulent bacteria and endotoxins, and their transfusion may be associated with significant morbidity and may even be lethal to the recipient. The prevalence of severe episodes of transfusion-associated sepsis has not been clearly established, but is probably of the order of 1 in 50,000 for platelet units and 1 in 500,000 for red blood cell units transfused. As a result of the increased recognition that such transfusion-associated septic episodes can occur, a variety of measures have been proposed to try to prevent and/or control the rate of contamination of blood products.

Bacteria↗

Blood donor-, apheresis-, and transfusion-related activities: results of the 1991 American Association of Blood Banks Institutional Membership Questionnaire.

Approximately 2154 regional blood centers and hospital-based blood banks and transfusion services responded to the 1991 American Association of Blood Banks Institutional Membership Questionnaire that elicited data from 1990. Information from 2144 institutions was considered valid. Questionnaire topics were donor blood collections, hemapheresis, perioperative cell salvage, component usage, and transfusion-associated diseases. Institutional members reported collecting 9.3 million units, of which 90.9 percent were for allogeneic use in the community, 6.0 percent were for autologous use, and 3.1 percent were directed donations. The percentage of directed-donor units that were crossed over for allogeneic use (51%) was greater than the percentage of units transfused to the designated patient (49%). Only 12.5 percent of institutions reported obtaining specific consent for transfusion. Of the 15.4 million transfused blood components, 8.5 million were red cells, 4.1 million were platelets, 1.8 million were fresh-frozen plasma, and 0.9 million were cryoprecipitate. There were 1263 reported cases of transfusion-associated hepatitis. Approximately 44 percent of the patients who were tested proved positive for hepatitis B surface antigen, and 80 percent of the patients who were tested proved positive for antibody to hepatitis C. The questionnaire's aggregate results can be used to assess current patterns of blood donation and transfusion activities.

Acquired Immunodeficiency Syndrome↗

[What present strategies are helpful in improving transfusion safety in France?].

Transfusion safety rests on measures ensuring that patients are transfused in accordance with the requirements of state-of-the-art scientific knowledge. This strict attitude is part of a quality approach which now applies to all fields of health. Transfusion is historically characterized by its ambivalence: it was the first medical discipline which integrated Quality Assurance concepts, it was also the first which proved unable to respond adequately in the face of uncontrolled risks. Today transfusion must create a system to rapidly: identify any risk, whether emergent or hypothetical; decide which action should be taken; monitor and assess corrective action; study the medico-economic impact of the whole approach. Quality assurance applies to every stage of the transfusion process, from blood donor to labile blood component recipient. This includes blood donor selection and biological control, labile blood component processing, qualification, transport and conditioning, prescription and distribution of blood components and transfused patient follow-up of. Quality controls, "safety locks", must be implemented at every stage to allow early problem detection, thus avoiding potentially dangerous attitudes and guaranteeing transfusion quality all along the process. Medical prescriptions must follow similar rules and meet Good Practice requirements defined by members of the medical and scientific community. A transfusion should not be prescribed unless it is absolutely necessary. In addition to sanitary surveillance, scientific surveillance must also be implemented to help transferring the findings of fundamental research to transfusion activities and continuously improve transfusion safety. INSERM is initiating sociological studies to identify and better understand donors' attitudes leading to risks. More sensitive tests based on nucleic acid amplification should reduce the incidence of residual viral risks. Various viral cell derivative inactivation techniques are being evaluated: the idea is to remove antigens to suppress the risk of post-transfusion alloimmunization. Numerous R&D; programs address substitution products. Transfusion safety requires all actors in the field of health being equally involved. Putting together experiences and know-how will continuously strengthen the quality approach adopted in transfusion.

Biotechnology↗

Blood collection and transfusion in the United States in 1997.

BACKGROUND: Collections, processing, and transfusions of blood and blood components in the US in 1997 were measured and compared with 1994 and prior years. STUDY DESIGN AND METHODS: Questionnaires were returned by 2391 blood centers, AABB member hospitals, nonmember hospitals, and other facilities. Statistical procedures were used to verify that the sample was representative and to estimate national collections and utilization. RESULTS: The gross domestic blood supply in the US in 1997 was 12,602,000 units, 5.5 percent less than in 1994. It included 11,741,000 units of allogeneic community blood, 643,000 units of autologous blood, and 205,000 units of allogeneic-directed blood. Platelet transfusions amounted to 9,037,000 platelet concentrate equivalent units, of which 62.4 percent were apheresis packs. Compared with 1994, total platelet units transfused increased by 14.9 percent and single-donor platelet units transfused increased by 31.7 percent, whereas platelet concentrate transfusion declined by 3.8 percent. Transfusions of FFP increased by 26.6 percent compared with 1994. CONCLUSIONS: The margin of US allogeneic blood supply in excess of allogeneic transfusions in 1997 was 630,000 units, 5.4 percent of total allogeneic supply as compared with margins in prior years ranging between 9.3 and 10.9 percent. Although overall allogeneic available supply in 1994 was adequate to meet transfusion demand, the decrease in the margin between 1994 and 1997 is cause for concern. The rate of whole-blood collections in 1997 per 1000 members of the population aged 18 to 65 years was 12.6 percent lower than 1994. The RBC transfusion rate per 1000 members of the population in 1997 remained nearly the same as in 1994. However, the rates of platelet and of plasma transfusions both increased.

Adolescent↗