Liberal or Restrictive Transfusion Strategy in Aneurysmal Subarachnoid Hemorrhage
Shane English, Anthony Delaney, Dean Fergusson, Michaël Chassé, Alexis F. Turgeon, François Lauzier, Angie Tuttle, Ofer Sadan, Donald Griesdale, Gary Redekop, Martin Chapman, Mathew Hannouche, Andreas H. Kramer, Ian Seppelt, Andrew Udy, Demetrios J. Kutsogiannis, Ryan Zarychanski, Frédérick D’Aragon, J. Gordon Boyd, Gavin Salt, Judith Bellapart, Gordon Wood, Luis Cava, Gwynedd E. Pickett, Lauren Koffman, Irene Watpool, Frances Bass, Naomi Hammond, Tim Ramsay, Ranjeeta Mallick, Damon C. Scales, Chris Andersen, Emily Fitzgerald, Phil Talbot, Dar Dowlatshahi, John Sinclair, Jason P. Acker, Shawn Marshall, Lauralyn McIntyre
Abstract
BACKGROUND: The effect of a liberal red-cell transfusion strategy as compared with a restrictive strategy in patients during the critical care period after an aneurysmal subarachnoid hemorrhage is unclear. METHODS: We randomly assigned critically ill adults with acute aneurysmal subarachnoid hemorrhage and anemia to a liberal strategy (mandatory transfusion at a hemoglobin level of ≤10 g per deciliter) or a restrictive strategy (optional transfusion at a hemoglobin level of ≤8 g per deciliter). The primary outcome was an unfavorable neurologic outcome, defined as a score of 4 or higher on the modified Rankin scale (range, 0 to 6, with higher scores indicating greater disability), at 12 months. Secondary outcomes included 12-month functional independence as assessed with the Functional Independence Measure (FIM; scores range from 18 to 126) and quality of life as assessed with the EuroQol five-dimension, five-level (EQ-5D-5L) utility index (scores range from -0.1 to 0.95) and a visual analogue scale (VAS; scores range from 0 to 100); on each assessment, higher scores indicate better health status or quality of life. RESULTS: A total of 742 patients underwent randomization at 23 centers. The analysis of the primary outcome at 12 months included 725 patients (97.7%). An unfavorable neurologic outcome occurred in 122 of 364 patients (33.5%) in the liberal-strategy group and in 136 of 361 patients (37.7%) in the restrictive-strategy group (risk ratio, 0.88; 95% confidence interval [CI], 0.72 to 1.09; P = 0.22). The mean (±SD) FIM score was 82.8±54.6 in the liberal-strategy group and 79.8±54.5 in the restrictive-strategy group (mean difference, 3.01; 95% CI, -5.49 to 11.51). The mean EQ-5D-5L utility index score was 0.5±0.4 in both groups (mean difference, 0.02; 95% CI, -0.04 to 0.09). The mean VAS score was 52.1±37.5 in the liberal-strategy group and 50±37.1 in the restrictive-strategy group (mean difference, 2.08; 95% CI, -3.76 to 7.93). The incidence of adverse events was similar in the two groups. CONCLUSIONS: In patients with aneurysmal subarachnoid hemorrhage and anemia, a liberal transfusion strategy did not result in a lower risk of an unfavorable neurologic outcome at 12 months than a restrictive strategy. (Funded by the Canadian Institutes of Health Research and others; SAHARA ClinicalTrials.gov number, NCT03309579.).