Jacques Lacroix1, Paul C Hébert, Dean A Fergusson, Alan Tinmouth, Deborah J Cook, John C Marshall, Lucy Clayton, Lauralyn McIntyre, Jeannie Callum, Alexis F Turgeon, Morris A Blajchman, Timothy S Walsh, Simon J Stanworth, Helen Campbell, Gilles Capellier, Pierre Tiberghien, Laurent Bardiaux, Leo van de Watering, Nardo J van der Meer, Elham Sabri, Dong Vo. 1. From Centre Hospitalier Universitaire (CHU) Sainte-Justine, Université de Montréal (J.L., L.C.) and Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (P.C.H.), Ottawa Hospital Research Institute, University of Ottawa, Ottawa (D.A.F., A.T., L.M., E.S., D.V.), McMaster University, Hamilton, ON (D.J.C., M.A.B.), University of Toronto, Toronto (J.C.M., J.C.), and Centre de Recherche du CHU de Québec, Université Laval, Quebec, QC (A.F.T.) - all in Canada; University of Edinburgh (T.S.W.) and NHS Blood and Transplant-Oxford University Hospitals NHS Trust, University of Oxford, Oxford (S.J.S., H.C.) - both in the United Kingdom; Université de Franche-Comté, Besançon (G.C., P.T.) and Établissement Français du Sang, La Plaine St. Denis (P.T., L.B.) - both in France; and Sanquin Blood Supply, Amsterdam (L.W.), Amphia Hospital, Breda and Oosterhout (N.J.M.), and TIAS School for Business and Society-Tilburg University, Tilburg (N.J.M.) - all in the Netherlands.
Abstract
BACKGROUND: Fresh red cells may improve outcomes in critically ill patients by enhancing oxygen delivery while minimizing the risks of toxic effects from cellular changes and the accumulation of bioactive materials in blood components during prolonged storage. METHODS: In this multicenter, randomized, blinded trial, we assigned critically ill adults to receive either red cells that had been stored for less than 8 days or standard-issue red cells (the oldest compatible units available in the blood bank). The primary outcome measure was 90-day mortality. RESULTS:Between March 2009 and May 2014, at 64 centers in Canada and Europe, 1211 patients were assigned to receive fresh red cells (fresh-blood group) and1219 patients were assigned to receive standard-issue red cells (standard-blood group). Red cells were stored a mean (±SD) of 6.1±4.9 days in the fresh-blood group as compared with 22.0±8.4 days in the standard-blood group (P<0.001). At 90 days, 448 patients (37.0%) in the fresh-blood group and 430 patients (35.3%) in the standard-blood group had died (absolute risk difference, 1.7 percentage points; 95% confidence interval [CI], -2.1 to 5.5). In the survival analysis, the hazard ratio for death in the fresh-blood group, as compared with the standard-blood group, was 1.1 (95% CI, 0.9 to 1.2; P=0.38). There were no significant between-group differences in any of the secondary outcomes (major illnesses; duration of respiratory, hemodynamic, or renal support; length of stay in the hospital; and transfusion reactions) or in the subgroup analyses. CONCLUSIONS: Transfusion of fresh red cells, as compared with standard-issue red cells, did not decrease the 90-day mortality among critically ill adults. (Funded by the Canadian Institutes of Health Research and others; Current Controlled Trials number, ISRCTN44878718.).
RCT Entities:
BACKGROUND: Fresh red cells may improve outcomes in critically ill patients by enhancing oxygen delivery while minimizing the risks of toxic effects from cellular changes and the accumulation of bioactive materials in blood components during prolonged storage. METHODS: In this multicenter, randomized, blinded trial, we assigned critically ill adults to receive either red cells that had been stored for less than 8 days or standard-issue red cells (the oldest compatible units available in the blood bank). The primary outcome measure was 90-day mortality. RESULTS: Between March 2009 and May 2014, at 64 centers in Canada and Europe, 1211 patients were assigned to receive fresh red cells (fresh-blood group) and 1219 patients were assigned to receive standard-issue red cells (standard-blood group). Red cells were stored a mean (±SD) of 6.1±4.9 days in the fresh-blood group as compared with 22.0±8.4 days in the standard-blood group (P<0.001). At 90 days, 448 patients (37.0%) in the fresh-blood group and 430 patients (35.3%) in the standard-blood group had died (absolute risk difference, 1.7 percentage points; 95% confidence interval [CI], -2.1 to 5.5). In the survival analysis, the hazard ratio for death in the fresh-blood group, as compared with the standard-blood group, was 1.1 (95% CI, 0.9 to 1.2; P=0.38). There were no significant between-group differences in any of the secondary outcomes (major illnesses; duration of respiratory, hemodynamic, or renal support; length of stay in the hospital; and transfusion reactions) or in the subgroup analyses. CONCLUSIONS: Transfusion of fresh red cells, as compared with standard-issue red cells, did not decrease the 90-day mortality among critically ill adults. (Funded by the Canadian Institutes of Health Research and others; Current Controlled Trials number, ISRCTN44878718.).
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