TY - JOUR
T1 - Effect of red blood cell storage duration on major postoperative complications in cardiac surgery
T2 - A randomized trial
AU - Koch, Colleen G.
AU - Sessler, Daniel I.
AU - Duncan, Andra E.
AU - Mascha, Edward J.
AU - Li, Liang
AU - Yang, Dongsheng
AU - Figueroa, Priscilla
AU - Sabik, Joseph F.
AU - Mihaljevic, Tomislav
AU - Svensson, Lars G.
AU - Blackstone, Eugene H.
N1 - Funding Information:
This study was supported by the Department of Outcomes Research at the Cleveland Clinic and in part by the Gus P. Karos Registry Fund, the Drs Sidney and Becca Fleischer Heart and Vascular Education Chair, and the Sheikh Hamdan bin Rashid Al Maktoum Distinguished Chair in Thoracic and Cardiovascular Surgery. These individuals and funding organizations played no role in the collection of data or analysis and interpretation of the data, and had no right to approve or disapprove publication of the final manuscript.
Publisher Copyright:
© 2019 The American Association for Thoracic Surgery
PY - 2020/12
Y1 - 2020/12
N2 - Background: Although observational studies suggest an association between transfusion of older red blood cell (RBC) units and increased postoperative risk, randomized trials have not supported this. The objective of this randomized trial was to test the effect of RBC storage age on outcomes after cardiac surgery. Methods: From July 2007 to May 2016, 3835 adults undergoing coronary artery bypass grafting, cardiac valve procedures, or ascending aorta repair, either alone or in combination, were randomized to transfusion of RBCs stored for ≤14 days (younger units) or for ≥20 days (older units) intraoperatively and throughout the postoperative hospitalization. According to protocol, 2448 patients were excluded because they did not receive RBC transfusions. Among the remaining 1387 modified intent-to-treat patients, 701 were randomized to receive younger RBC units (median age, 11 days) and the remaining 686 to receive older units (median age, 25 days). The primary endpoint was composite morbidity and mortality, analyzed using a generalized estimating equation (GEE) model. The trial was discontinued midway owing to enrollment constraints. Results: A total of 5470 RBC units were transfused, including 2783 in the younger RBC storage group and 2687 in the older RBC storage group. The GEE average relative-effect odds ratio was 0.77 (95% confidence interval [CI], 0.50-1.19; P = .083) for the composite morbidity and mortality endpoint. In-hospital mortality was lower for the younger RBC storage group (2.1% [n = 15] vs 3.4% [n = 23]), as was occurrence of other adverse events except for atrial fibrillation, although all CIs crossed 1.0. Conclusions: This clinical trial, which was stopped at its midpoint owing to enrollment constraints, supports neither the efficacy nor the futility of transfusing either younger or older RBC units. The effects of transfusing RBCs after even more prolonged storage (35-42 days) remains untested.
AB - Background: Although observational studies suggest an association between transfusion of older red blood cell (RBC) units and increased postoperative risk, randomized trials have not supported this. The objective of this randomized trial was to test the effect of RBC storage age on outcomes after cardiac surgery. Methods: From July 2007 to May 2016, 3835 adults undergoing coronary artery bypass grafting, cardiac valve procedures, or ascending aorta repair, either alone or in combination, were randomized to transfusion of RBCs stored for ≤14 days (younger units) or for ≥20 days (older units) intraoperatively and throughout the postoperative hospitalization. According to protocol, 2448 patients were excluded because they did not receive RBC transfusions. Among the remaining 1387 modified intent-to-treat patients, 701 were randomized to receive younger RBC units (median age, 11 days) and the remaining 686 to receive older units (median age, 25 days). The primary endpoint was composite morbidity and mortality, analyzed using a generalized estimating equation (GEE) model. The trial was discontinued midway owing to enrollment constraints. Results: A total of 5470 RBC units were transfused, including 2783 in the younger RBC storage group and 2687 in the older RBC storage group. The GEE average relative-effect odds ratio was 0.77 (95% confidence interval [CI], 0.50-1.19; P = .083) for the composite morbidity and mortality endpoint. In-hospital mortality was lower for the younger RBC storage group (2.1% [n = 15] vs 3.4% [n = 23]), as was occurrence of other adverse events except for atrial fibrillation, although all CIs crossed 1.0. Conclusions: This clinical trial, which was stopped at its midpoint owing to enrollment constraints, supports neither the efficacy nor the futility of transfusing either younger or older RBC units. The effects of transfusing RBCs after even more prolonged storage (35-42 days) remains untested.
KW - distinct-effects generalized estimating equation model
KW - postoperative outcomes
KW - transfusion
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U2 - 10.1016/j.jtcvs.2019.09.165
DO - 10.1016/j.jtcvs.2019.09.165
M3 - Article
C2 - 31813538
AN - SCOPUS:85076248206
SN - 0022-5223
VL - 160
SP - 1505-1514.e3
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 6
ER -