Marie E Steiner1, Paul M Ness, Susan F Assmann, Darrell J Triulzi, Steven R Sloan, Meghan Delaney, Suzanne Granger, Elliott Bennett-Guerrero, Morris A Blajchman, Vincent Scavo, Jeffrey L Carson, Jerrold H Levy, Glenn Whitman, Pamela D'Andrea, Shelley Pulkrabek, Thomas L Ortel, Larissa Bornikova, Thomas Raife, Kathleen E Puca, Richard M Kaufman, Gregory A Nuttall, Pampee P Young, Samuel Youssef, Richard Engelman, Philip E Greilich, Ronald Miles, Cassandra D Josephson, Arthur Bracey, Rhonda Cooke, Jeffrey McCullough, Robert Hunsaker, Lynne Uhl, Janice G McFarland, Yara Park, Melissa M Cushing, Charles T Klodell, Ravindra Karanam, Pamela R Roberts, Cornelius Dyke, Eldad A Hod, Christopher P Stowell. 1. From Fairview-University Medical Center, Minneapolis (M.E.S., S.P., J.M.), and Mayo Clinic, Rochester (G.A.N.) - both in Minnesota; Johns Hopkins University (P.M.N., G.W.) and University of Maryland (R.C.) - both in Baltimore; New England Research Institutes, Data Coordinating Center, Watertown (S.F.A., S.G.), Boston Children's Hospital (S.R.S.), Massachusetts General Hospital (L.B., C.P.S.), Brigham and Women's Hospital (R.M.K.), Tufts University (R.E.), St. Elizabeth's Medical Center (R.H.), and Beth Israel Deaconess Medical Center (L.U.), Boston, and Baystate Medical Center, Springfield (R.E.) - all in Massachusetts; University of Pittsburgh and University of Pittsburgh-Mercy Hospital, Pittsburgh (D.J.T., P.D.); Puget Sound Blood Center and University of Washington (M.D.) and Swedish Medical Center (S.Y.) - all in Seattle; Duke University, Durham (E.B.-G., J.H.L., T.L.O.), and University of North Carolina, Chapel Hill (Y.P.) - both in North Carolina; McMaster University, Hamilton, ON, Canada (M.A.B.); Indiana-Ohio Heart and St. Joseph Hospital (V.S.) - both in Fort Wayne, IN; Rutgers Robert Wood Johnson Medical School, New Brunswick (J.L.C.), and Newark Beth Israel Medical Center, Newark (R.K.) - both in New Jersey; University of Iowa, Iowa City (T.R.); Aurora St. Luke's Medical Center (K.E.P.) and Froedert Memorial Lutheran Hospital (J.G.M.), Milwaukee, and Aspirus Heart and Vascular Institute, Wausau (R.M.) - all in Wisconsin; Vanderbilt University, Nashville (P.P.Y.); University of Texas Southwestern Medical Center, Dallas (P.E.G.); Children's Healthcare of Atlanta, Emory University, and Emory University Hospital, Atlanta (C.D.J.); St. Luke's-Texas Heart Institute, Houston (A.B.); Weill Cornell Medical College (M.M.C.) and Columbia University Medical Center (E.A.H.) - both in New York; University of Florida, Gainesville (C.T.K.); University of Oklahoma, Oklahoma City (P.R.R.); and University of North Dakota School of Medicine and Health Sciences, Fargo (C.D.).
Abstract
BACKGROUND: Some observational studies have reported that transfusion of red-cell units that have been stored for more than 2 to 3 weeks is associated with serious, even fatal, adverse events. Patients undergoing cardiac surgery may be especially vulnerable to the adverse effects of transfusion. METHODS: We conducted a randomized trial at multiple sites from 2010 to 2014. Participants 12 years of age or older who were undergoing complex cardiac surgery and were likely to undergo transfusion of red cells were randomly assigned to receive leukocyte-reduced red cells stored for 10 days or less (shorter-term storage group) or for 21 days or more (longer-term storage group) for all intraoperative and postoperative transfusions. The primary outcome was the change in Multiple Organ Dysfunction Score (MODS; range, 0 to 24, with higher scores indicating more severe organ dysfunction) from the preoperative score to the highest composite score through day 7 or the time of death or discharge. RESULTS: The median storage time of red-cell units provided to the 1098 participants who receivedred-cell transfusion was 7 days in the shorter-term storage group and 28 days in the longer-term storage group. The mean change in MODS was an increase of 8.5 and 8.7 points, respectively (95% confidence interval for the difference, -0.6 to 0.3; P=0.44). The 7-day mortality was 2.8% in the shorter-term storage group and 2.0% in the longer-term storage group (P=0.43); 28-day mortality was 4.4% and 5.3%, respectively (P=0.57). Adverse events did not differ significantly between groups except that hyperbilirubinemia was more common in the longer-term storage group. CONCLUSIONS: The duration of red-cell storage was not associated with significant differences in the change in MODS. We did not find that the transfusion of red cells stored for 10 days or less was superior to the transfusion of red cells stored for 21 days or more among patients 12 years of age or older who were undergoing complex cardiac surgery. (Funded by the National Heart, Lung, and Blood Institute; RECESS ClinicalTrials.gov number, NCT00991341.).
RCT Entities:
BACKGROUND: Some observational studies have reported that transfusion of red-cell units that have been stored for more than 2 to 3 weeks is associated with serious, even fatal, adverse events. Patients undergoing cardiac surgery may be especially vulnerable to the adverse effects of transfusion. METHODS: We conducted a randomized trial at multiple sites from 2010 to 2014. Participants 12 years of age or older who were undergoing complex cardiac surgery and were likely to undergo transfusion of red cells were randomly assigned to receive leukocyte-reduced red cells stored for 10 days or less (shorter-term storage group) or for 21 days or more (longer-term storage group) for all intraoperative and postoperative transfusions. The primary outcome was the change in Multiple Organ Dysfunction Score (MODS; range, 0 to 24, with higher scores indicating more severe organ dysfunction) from the preoperative score to the highest composite score through day 7 or the time of death or discharge. RESULTS: The median storage time of red-cell units provided to the 1098 participants who received red-cell transfusion was 7 days in the shorter-term storage group and 28 days in the longer-term storage group. The mean change in MODS was an increase of 8.5 and 8.7 points, respectively (95% confidence interval for the difference, -0.6 to 0.3; P=0.44). The 7-day mortality was 2.8% in the shorter-term storage group and 2.0% in the longer-term storage group (P=0.43); 28-day mortality was 4.4% and 5.3%, respectively (P=0.57). Adverse events did not differ significantly between groups except that hyperbilirubinemia was more common in the longer-term storage group. CONCLUSIONS: The duration of red-cell storage was not associated with significant differences in the change in MODS. We did not find that the transfusion of red cells stored for 10 days or less was superior to the transfusion of red cells stored for 21 days or more among patients 12 years of age or older who were undergoing complex cardiac surgery. (Funded by the National Heart, Lung, and Blood Institute; RECESS ClinicalTrials.gov number, NCT00991341.).
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