Nancy M Heddle1, Richard J Cook1, Donald M Arnold1, Yang Liu1, Rebecca Barty1, Mark A Crowther1, P J Devereaux1, Jack Hirsh1, Theodore E Warkentin1, Kathryn E Webert1, David Roxby1, Magdalena Sobieraj-Teague1, Andrea Kurz1, Daniel I Sessler1, Priscilla Figueroa1, Martin Ellis1, John W Eikelboom1. 1. From the Departments of Medicine (N.M.H., D.M.A., Y.L., R.B., M.A.C., P.J.D., J.H., T.E.W., J.W.E.), Pathology and Molecular Medicine (N.M.H., M.A.C., T.E.W., K.E.W.), and Clinical Epidemiology and Biostatistics (N.M.H., P.J.D.) and McMaster Centre for Transfusion Research (N.M.H., R.J.C., D.M.A., Y.L., R.B., T.E.W., K.E.W.), McMaster University, Canadian Blood Services (N.M.H., D.M.A., K.E.W.), the Population Health Research Institute (P.J.D., J.W.E.), and the Thrombosis and Atherosclerosis Research Institute (J.W.E.), Hamilton, ON, and the Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, ON (R.J.C.) - all in Canada; SA Pathology Transfusion Service, Flinders Medical Centre and Flinders University, Adelaide, SA, Australia (D.R., M.S.-T.); the Departments of General Anesthesiology (A.K.) and Outcomes Research (A.K., D.I.S.), Anesthesiology Institute, and the Robert J. Tomsich Pathology and Laboratory Medicine Institute and the Department of Laboratory Medicine (P.F.), Cleveland Clinic, Cleveland; and Meir Medical Center Kfar Saba and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (M.E.).
Abstract
BACKGROUND: Randomized, controlled trials have suggested that the transfusion of blood after prolonged storage does not increase the risk of adverse outcomes among patients, although most of these trials were restricted to high-risk populations and were not powered to detect small but clinically important differences in mortality. We sought to find out whether the duration of blood storage would have an effect on mortality after transfusion in a general population of hospitalized patients. METHODS: In this pragmatic, randomized, controlled trial conducted at six hospitals in four countries, we randomly assigned patients who required a red-cell transfusion to receive blood that had been stored for the shortest duration (short-term storage group) or the longest duration (long-term storage group) in a 1:2 ratio. Only patients with type A or O blood were included in the primary analysis, since pilot data suggested that our goal of achieving a difference in the mean duration of blood storage of at least 10 days would not be possible with other blood types. Written informed consent was waived because all the patients received treatment consistent with the current standard of care. The primary outcome was in-hospital mortality, which was estimated by means of a logistic-regression model after adjustment for study center and patient blood type. RESULTS:From April 2012 through October 2015, a total of 31,497 patients underwent randomization. Of these patients, 6761 who did not meet all the enrollment criteria were excluded after randomization. The primary analysis included 20,858 patients with type A or O blood. Of these patients, 6936 were assigned to the short-term storage group and 13,922 to the long-term storage group. The mean storage duration was 13.0 days in the short-term storage group and 23.6 days in the long-term storage group. There were 634 deaths (9.1%) in the short-term storage group and 1213 (8.7%) in the long-term storage group (odds ratio, 1.05; 95% confidence interval [CI], 0.95 to 1.16; P=0.34). When the analysis was expanded to include the 24,736 patients with any blood type, the results were similar, with rates of death of 9.1% and 8.8%, respectively (odds ratio, 1.04; 95% CI, 0.95 to 1.14; P=0.38). Additional results were consistent in three prespecified high-risk subgroups (patients undergoing cardiovascular surgery, those admitted to intensive care, and those with cancer). CONCLUSIONS: Among patients in a general hospital population, there was no significant difference in the rate of death among those who underwent transfusion with the freshest available blood and those who underwent transfusion according to the standard practice of transfusing the oldest available blood. (Funded by the Canadian Institutes of Health Research and others; INFORM Current Controlled Trials number, ISRCTN08118744 .).
RCT Entities:
BACKGROUND: Randomized, controlled trials have suggested that the transfusion of blood after prolonged storage does not increase the risk of adverse outcomes among patients, although most of these trials were restricted to high-risk populations and were not powered to detect small but clinically important differences in mortality. We sought to find out whether the duration of blood storage would have an effect on mortality after transfusion in a general population of hospitalized patients. METHODS: In this pragmatic, randomized, controlled trial conducted at six hospitals in four countries, we randomly assigned patients who required a red-cell transfusion to receive blood that had been stored for the shortest duration (short-term storage group) or the longest duration (long-term storage group) in a 1:2 ratio. Only patients with type A or O blood were included in the primary analysis, since pilot data suggested that our goal of achieving a difference in the mean duration of blood storage of at least 10 days would not be possible with other blood types. Written informed consent was waived because all the patients received treatment consistent with the current standard of care. The primary outcome was in-hospital mortality, which was estimated by means of a logistic-regression model after adjustment for study center and patient blood type. RESULTS: From April 2012 through October 2015, a total of 31,497 patients underwent randomization. Of these patients, 6761 who did not meet all the enrollment criteria were excluded after randomization. The primary analysis included 20,858 patients with type A or O blood. Of these patients, 6936 were assigned to the short-term storage group and 13,922 to the long-term storage group. The mean storage duration was 13.0 days in the short-term storage group and 23.6 days in the long-term storage group. There were 634 deaths (9.1%) in the short-term storage group and 1213 (8.7%) in the long-term storage group (odds ratio, 1.05; 95% confidence interval [CI], 0.95 to 1.16; P=0.34). When the analysis was expanded to include the 24,736 patients with any blood type, the results were similar, with rates of death of 9.1% and 8.8%, respectively (odds ratio, 1.04; 95% CI, 0.95 to 1.14; P=0.38). Additional results were consistent in three prespecified high-risk subgroups (patients undergoing cardiovascular surgery, those admitted to intensive care, and those with cancer). CONCLUSIONS: Among patients in a general hospital population, there was no significant difference in the rate of death among those who underwent transfusion with the freshest available blood and those who underwent transfusion according to the standard practice of transfusing the oldest available blood. (Funded by the Canadian Institutes of Health Research and others; INFORM Current Controlled Trials number, ISRCTN08118744 .).
Authors: Gustaf Edgren; Henrik Ullum; Klaus Rostgaard; Christian Erikstrup; Ulrik Sartipy; Martin J Holzmann; Olof Nyrén; Henrik Hjalgrim Journal: JAMA Intern Med Date: 2017-06-01 Impact factor: 21.873
Authors: Angelo D'Alessandro; Rachel Culp-Hill; Julie A Reisz; Mikayla Anderson; Xiaoyun Fu; Travis Nemkov; Sarah Gehrke; Connie Zheng; Tamir Kanias; Yuelong Guo; Grier Page; Mark T Gladwin; Steve Kleinman; Marion Lanteri; Mars Stone; Michael Busch; James C Zimring Journal: Transfusion Date: 2018-10-24 Impact factor: 3.157