Liberal or Restrictive Transfusion Strategy in Aneurysmal Subarachnoid Hemorrhage

Shane W English; Anthony Delaney; Dean A Fergusson; Michaël Chassé; Alexis F Turgeon; François Lauzier; Angie Tuttle; Ofer Sadan; Donald E Griesdale; Gary Redekop; Martin Chapman; Mathew Hannouche; Andreas 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 Pickett; Lauren Koffman; Irene Watpool; Frances Bass; Naomi Hammond; Tim Ramsay; Ranjeeta Mallick; Damon C Scales; Christopher R Andersen; Emily Fitzgerald; Phil Talbot; Dar Dowlatshahi; John Sinclair; Jason Acker; Shawn C Marshall; Lauralyn McIntyre; SAHARA Trial Investigators on behalf of the Canadian Critical Care Trials Group

doi:10.1056/NEJMoa2410962

Liberal or Restrictive Transfusion Strategy in Aneurysmal Subarachnoid Hemorrhage

N Engl J Med. 2024 Dec 9. doi: 10.1056/NEJMoa2410962. Online ahead of print.

Authors

Shane W English¹, Anthony Delaney¹, Dean A Fergusson¹, Michaël Chassé¹, Alexis F Turgeon¹, François Lauzier¹, Angie Tuttle¹, Ofer Sadan¹, Donald E Griesdale¹, Gary Redekop¹, Martin Chapman¹, Mathew Hannouche¹, Andreas Kramer¹, Ian Seppelt¹, Andrew Udy¹, Demetrios J Kutsogiannis¹, Ryan Zarychanski¹, Frédérick D'Aragon¹, J Gordon Boyd¹, Gavin Salt¹, Judith Bellapart¹, Gordon Wood¹, Luis Cava¹, Gwynedd Pickett¹, Lauren Koffman¹, Irene Watpool¹, Frances Bass¹, Naomi Hammond¹, Tim Ramsay¹, Ranjeeta Mallick¹, Damon C Scales¹, Christopher R Andersen¹, Emily Fitzgerald¹, Phil Talbot¹, Dar Dowlatshahi¹, John Sinclair¹, Jason Acker¹, Shawn C Marshall¹, Lauralyn McIntyre¹; SAHARA Trial Investigators on behalf of the Canadian Critical Care Trials Group

Affiliation

¹ From Ottawa Hospital Research Institute, Ottawa (S.W.E., D.A.F., A.T., I.W., T.R., R.M., D.D., S.C.M., L.M.); the Department of Medicine, Division of Critical Care, Faculty of Medicine, University of Ottawa, Ottawa (S.W.E., L.M.); School of Epidemiology and Public Health University of Ottawa, Ottawa (S.W.E., D.A.F., L.M.); Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa (D.A.F., D.D., S.C.M.); George Institute for Global Health, Sydney (A.D., F.B., N.H., C.R.A., P.T.); Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW, Australia (A.D., N.H., C.R.A., E.F.); the Faculty of Medicine and Health, University of Sydney Northern Clinical School, St. Leonards, NSW, Australia (A.D., C.R.A.); Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (A.D., A.U.); the Department of Medicine, Centre Hospitalier de l'Université de Montréal, Montreal (M. Chassé); the Department of Medicine, Faculty of Medicine, Université de Montréal, Montreal (M. Chassé); the Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Faculty of Medicine, Université Laval, Quebec, QC, Canada (A.F.T., F.L.); Population Health and Optimal Health Practice Research Unit, Centre Hospitalier Universitaire de Québec-Université Laval Research Center, Quebec, QC, Canada (A.F.T., F.L.); the Department of Anesthesia, Critical Care Medicine Service, Hôpital de L'Enfant-Jésus, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (A.F.T., F.L.); the Department of Medicine, Faculty of Medicine, Université Laval, Quebec, QC, Canada (F.L.); the Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University School of Medicine, Emory University Hospital and Grady Memorial Hospital, Atlanta (O.S.); the Department of Medicine, Division of Critical Care Medicine, Faculty of Medicine, Vancouver General Hospital, University of British Columbia, Vancouver, Canada (D.E.G.); the Division of Neurosurgery, Vancouver General Hospital, Vancouver, BC, Canada (G.R.); the Division of Neurosurgery, Department of Surgery, the University of British Columbia, Vancouver, Canada (G.R.); Neurocritical Care and Anesthesia, Sunnybrook Health Sciences Centre and Sunnybrook Research Institute, Toronto (M. Chapman); McGill University, Montreal (M.H.); the Departments of Critical Care Medicine and Clinical Neurosciences, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada (A.K.); Nepean Clinical School, University of Sydney, Sydney (I.S.); the Department of Clinical Medicine, Macquarie University, Sydney (I.S.); the Critical Care and Trauma Division, the George Institute for Global Health, Sydney (I.S.); the Department of Intensive Care and Hyperbaric Medicine, the Alfred, Melbourne, VIC, Australia (A.U.); the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada (D.J.K.); the Department of Internal Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada (R.Z.); the Department of Medical Oncology/Hematology and the Paul Albrechtsen Research Institute, Cancer Care Manitoba, Winnipeg, Canada (R.Z.); the Department of Anesthesiology, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, QC, Canada (F.D.); Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada (F.D.); the Department of Medicine, Division of Neurology, School of Medicine, Queen's University, Kingston, ON, Canada (J.G.B.); Department of Critical Care Medicine, School of Medicine, Queen's University, Kingston, ON, Canada (J.G.B.); the Intensive Care Unit, Prince of Wales Hospital, Randwick, NSW, Australia (G.S.); the Department of Intensive Care, Royal Brisbane and Women's Hospital, Herston, QLD, Australia (J.B.); University of Queensland, Brisbane, Australia (J.B.); the Department of Adult Intensive Care, Island Health Authority, Victoria, BC, Canada (G.W.); University of Colorado School of Medicine, Aurora (L.C.); the Department of Surgery, Division of Neurosurgery, Dalhousie University, Halifax, NS, Canada (G.P.); QEII Health Sciences Centre, Halifax, NS, Canada (G.P.); Lewis Katz School of Medicine, Temple University, Philadelphia (L.K.); Rush University Medical Center, Chicago (L.K.); Royal North Shore Hospital, Sydney (F.B.); the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto (D.C.S.); the Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto (D.C.S.); the Kirby Institute, University of New South Wales, Kensington, Australia (C.R.A.); the Department of Surgery, Division of Neurosurgery, Faculty of Medicine, University of Ottawa, Ottawa (J.S.); Canadian Blood Services, Edmonton, AB, Canada (J.A.); the Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Canada (J.A.); and Physical Medicine and Rehabilitation, Bruyere Continuing Care, Ottawa (S.C.M.).

PMID: 39655786
DOI: 10.1056/NEJMoa2410962

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.).

Associated data

ClinicalTrials.gov/NCT03309579

Abstract

Associated data

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