BACKGROUND: Several mechanisms have been proposed as possible causes of transfusion-related immunomodulation (TRIM) after allogeneic transfusion. If one of these mechanisms, the release of mediators of immunity and inflammation ("biologic response modifiers"[BRMs]) from disintegrating blood cells during storage of blood products, really causes TRIM, it should in principle also occur after autologous transfusion. As a consequence, prestorage leukoreduction of autologous blood should be able to prevent the clinical consequences of TRIM after autologous transfusion. STUDY DESIGN AND METHODS: This hypothesis was investigated in a multicenter, double-blind, randomized controlled trial. A total of 1089 patients scheduled for total hip arthroplasty and eligible for preoperative autologous blood donation were randomly assigned to receive autologous whole blood (AWB) either unmodified or leukoreduced when transfusion was indicated. RESULTS: Neither the primary study outcome, that is, the overall postoperative infection rate (17.3% vs. 17.6%, p = 0.59), nor several secondary outcomes like median length of hospital stay (14 days vs. 14 days, p = 0.17) were significantly different between groups, whether analyzed according to the intention-to-treat principle or "as treated." CONCLUSION: This trial provides strong evidence, from clinically relevant outcome data, that leukoreduction of AWB does not improve postoperative patient outcome and that the release of BRMs from disintegrating blood cells during storage cannot explain the immunomodulatory effect of blood transfusion.
RCT Entities:
BACKGROUND: Several mechanisms have been proposed as possible causes of transfusion-related immunomodulation (TRIM) after allogeneic transfusion. If one of these mechanisms, the release of mediators of immunity and inflammation ("biologic response modifiers"[BRMs]) from disintegrating blood cells during storage of blood products, really causes TRIM, it should in principle also occur after autologous transfusion. As a consequence, prestorage leukoreduction of autologous blood should be able to prevent the clinical consequences of TRIM after autologous transfusion. STUDY DESIGN AND METHODS: This hypothesis was investigated in a multicenter, double-blind, randomized controlled trial. A total of 1089 patients scheduled for total hip arthroplasty and eligible for preoperative autologous blood donation were randomly assigned to receive autologous whole blood (AWB) either unmodified or leukoreduced when transfusion was indicated. RESULTS: Neither the primary study outcome, that is, the overall postoperative infection rate (17.3% vs. 17.6%, p = 0.59), nor several secondary outcomes like median length of hospital stay (14 days vs. 14 days, p = 0.17) were significantly different between groups, whether analyzed according to the intention-to-treat principle or "as treated." CONCLUSION: This trial provides strong evidence, from clinically relevant outcome data, that leukoreduction of AWB does not improve postoperative patient outcome and that the release of BRMs from disintegrating blood cells during storage cannot explain the immunomodulatory effect of blood transfusion.
Authors: Margaret A Olsen; Anne M Butler; Denise M Willers; Gilad A Gross; Preetishma Devkota; Victoria J Fraser Journal: Infect Control Hosp Epidemiol Date: 2010-01 Impact factor: 3.254