Colleen G Koch1, Daniel I Sessler2, Andra E Duncan3, Edward J Mascha4, Liang Li5, Dongsheng Yang4, Priscilla Figueroa6, Joseph F Sabik7, Tomislav Mihaljevic8, Lars G Svensson8, Eugene H Blackstone9. 1. Department of Anesthesiology and Critical Care Medicine, Johns Hopkins Medicine, Baltimore, Md. Electronic address: ckoch11@jhmi.edu. 2. Department of Outcomes Researc, Cleveland Clinic, Cleveland, Ohio. 3. Department of Cardiothoracic Anesthesiology, Cleveland Clinic, Cleveland, Ohio. 4. Department of Outcomes Researc, Cleveland Clinic, Cleveland, Ohio; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio. 5. Division of Science, Department of Biostatistics, MD Anderson Cancer Center, Houston, Tex. 6. Department of Clinical Pathology, Cleveland Clinic, Cleveland, Ohio. 7. Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio. 8. Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. 9. Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
Abstract
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.
RCT Entities:
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.
Authors: Steffen M Recktenwald; Marcelle G M Lopes; Stephana Peter; Sebastian Hof; Greta Simionato; Kevin Peikert; Andreas Hermann; Adrian Danek; Kai van Bentum; Hermann Eichler; Christian Wagner; Stephan Quint; Lars Kaestner Journal: Front Physiol Date: 2022-04-27 Impact factor: 4.755