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Randomized Controlled Trial Multicenter Study Comparative Study Pragmatic Clinical Trial
Liberal or Restrictive Transfusion Strategy in Patients with Traumatic Brain Injury.
- Alexis F Turgeon, Dean A Fergusson, Lucy Clayton, Marie-Pier Patton, Xavier Neveu, Timothy S Walsh, Annemarie Docherty, Luiz M Malbouisson, Sébastien Pili-Floury, Shane W English, Ryan Zarychanski, Lynne Moore, Paule Lessard Bonaventure, Vincent Laroche, Michael Verret, Damon C Scales, AdhikariNeill K JNKJFrom the Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine (A.F.T., M.V., M.S.-O., F. Lauzier), the Department of Social and Preventive Medicine (L.M.), the Department of Surgery, Division of N, Jonathan Greenbaum, Andreas Kramer, ReyVanesa GarneloVGFrom the Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine (A.F.T., M.V., M.S.-O., F. Lauzier), the Department of Social and Preventive Medicine (L.M.), the Department of Surgery, Division of Ne, Ian Ball, Kosar Khwaja, Matt Wise, Daniel Harvey, François Lamontagne, Russell Chabanne, Almunder Algird, Stephan Krueper, Julien Pottecher, Frederick Zeiler, Jonathan Rhodes, Andrea Rigamonti, BurnsKaren E AKEA0000-0002-9967-5424From the Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine (A.F.T., M.V., M.S.-O., F. Lauzier), the Department of Social and Preventive Medicine (L.M.), the Department of Surger, John Marshall, Donald E Griesdale, Laís Silva Sisconetto, Demetrios J Kutsogiannis, Claire Roger, Robert Green, J Gordon Boyd, Judith Wright, Emmanuel Charbonney, Priya Nair, Timothy Astles, Eric Sy, Paul C Hébert, Michael Chassé, Alwyn Gomez, Tim Ramsay, Monica Taljaard, Alison Fox-Robichaud, Alan Tinmouth, Maude St-Onge, Olivier Costerousse, François Lauzier, and HEMOTION Trial Investigators on behalf of the Canadian Critical Care Trials Group, the Canadian Perioperative Anesthesia Clinical Trials Group, and the Canadian Traumatic Brain Injury Research Consortium.
- From the Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine (A.F.T., M.V., M.S.-O., F. Lauzier), the Department of Social and Preventive Medicine (L.M.), the Department of Surgery, Division of Neurosurgery (P.L.B.), the Department of Medicine (V.L., F. Lauzier), and the Department of Family and Emergency Medicine (M.S.-O.), Faculty of Medicine, Université Laval, the Population Health and Optimal Health Practice Unit, Centre Hospitalier Universitaire de Québec-Université Laval Research Center (A.F.T., L.C., M.-P.P., X.N., L.M., P.L.B., M.V., M.S.-O., O.C., F. Lauzier), and the Department of Anesthesia, Critical Care Medicine Service, Hôpital de L'Enfant-Jésus, Centre Hospitalier Universitaire de Québec-Université Laval (A.F.T., F. Lauzier), Quebec City, QC, Ottawa Hospital Research Institute (D.A.F., S.W.E., T.R., M.T., A.T.), the School of Epidemiology and Public Health (D.A.F., S.W.E., T.R., M.T., A.T.), the Division of Critical Care (S.W.E.), the Division of Hematology (A.T.), and the Division of Palliative Care (P.C.H.), the Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (L.C.), the Department of Internal Medicine (R.Z.), the Departments of Surgery and of Human Anatomy and Cell Science (F.Z., A.G.), Rady Faculty of Health Sciences, and the Biomedical Engineering Program, Faculty of Engineering (F.Z.), University of Manitoba, and the Department of Medical Oncology-Hematology and the Paul Albrechtsen Research Institute, CancerCare Manitoba (R.Z.), Winnipeg, the Department of Critical Care Medicine, Sunnybrook Health Sciences Center and Sunnybrook Research Institute (D.C.S., N.K.J.A.), and the Interdepartmental Division of Critical Care Medicine, University of Toronto (D.C.S., N.K.J.A., A.R., K.E.A.B., J.M.), Toronto, the Departments of Critical Care Medicine and Clinical Neurosciences, Hotchkiss Brain Institute, University of Calgary, Calgary, AB (A.K.), the Departments of Medicine and of Epidemiology and Biostatistics, Western University, London, ON (I.B.), the Departments of Surgery and Critical Care Medicine, McGill University Health Centre, Montreal (K.K.), the Department of Medicine, Faculty of Medicine, and Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, QC (F. Lamontagne), the Department of Surgery, Division of Neurosurgery, McMaster University, Hamilton Health Sciences, Hamilton, ON (A.A.), the Department of Anesthesia, St. Michael's Hospital, University of Toronto (A.R.), the Applied Health Research Centre, Li Ka Shing Knowledge Institute, and the Department of Critical Care, Unity Health Toronto-St. Michael's Hospital (K.E.A.B., J.M.), Toronto, the Departments of Medicine (A.F.-R.) and Health Research Methods, Evidence and Impact (K.E.A.B.), McMaster University, Hamilton, ON, the Department of Medicine, Division of Critical Care Medicine, Faculty of Medicine, Vancouver General Hospital, University of British Columbia, Vancouver (D.E.G.), the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton (D.J.K.), Trauma Nova Scotia, Nova Scotia Health, and the Departments of Critical Care, Emergency Medicine, and Anesthesia and Surgery, Dalhousie University, Halifax (R.G.), the Department of Medicine, Division of Neurology, and the Department of Critical Care Medicine, School of Medicine, Queen's University, Kingston, ON (J.G.B.), the Department of Medicine, Centre Hospitalier de l'Université de Montréal, and the Department of Medicine, Faculty of Medicine, Université de Montréal, Montreal (E.C., M.C.), Centre Intégré Universitaire de Santé et de Services Sociaux (CIUSSS) de la Mauricie-et-du-Centre-du-Québec, Trois-Rivières (E.C.), the University of Saskatchewan, College of Medicine, and Saskatchewan Health Authority-Regina Area, Regina (E.S.), and Bruyère Research Institute, University of Ottawa, Ottawa (P.C.H.) - all in Canada; Usher Institute of Population Health Sciences (T.S.W., A.D.) and the Department of Anaesthesia, Critical Care, and Pain Medicine (T.S.W., A.D., J.R.), Edinburgh Medical School, University of Edinburgh, Edinburgh, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford (J.G.), the Department of Critical Care Medicine, Imperial College Healthcare NHS Trust, St. Mary's Hospital, London (V.G.R.), Cardiff University and the University of Wales Hospital, Cardiff (M.W.), Nottingham University Hospitals NHS Trust, Nottingham (D.H.), University Hospitals North Midlands-Royal Stoke Hospital, Stoke-on-Trent (S.K.), the Division of Anaesthesia, Addenbrooke's Hospital, University of Cambridge, Cambridge (F.Z.), James Cook University Hospital, Middlesbrough (J.W.), and the Walton NHS Foundation Trust (P.N.) and the Department of Intensive Care Medicine, Liverpool University Hospitals NHS (T.A.), Liverpool - all in the United Kingdom; Surgical Intensive Care Unit, Anesthesiology Division, Hospital das Clínicas, University of São Paulo Medical School (L.M.M.), and the Intensive Care Unit, Hospital de Amor de Nossa Senhora (L.S.S.) - both in São Paulo; the Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besançon, Besançon (S.P.-F.), Département Anesthésie Réanimation et Médecine Périopératoire, Centre Hospitalier Universitaire (CHU) de Clermont-Ferrand, Clermont-Ferrand (R.C.), Hôpital de Hautepierre, Service d'Anesthésie-Réanimation et Médecine Péri-Opératoire, Hôpitaux Universitaires de Strasbourg, Strasbourg (J.P.), and UR-UM103 IMAGINE, University of Montpellier, Division of Anesthesia and Critical Care, Pain, and Emergency Medicine, Nîmes University Hospital, Montpellier (C.R.) - all in France.
- N. Engl. J. Med. 2024 Aug 22; 391 (8): 722735722-735.
BackgroundThe effect of a liberal transfusion strategy as compared with a restrictive strategy on outcomes in critically ill patients with traumatic brain injury is unclear.MethodsWe randomly assigned adults with moderate or severe traumatic brain injury and anemia to receive transfusion of red cells according to a liberal strategy (transfusions initiated at a hemoglobin level of ≤10 g per deciliter) or a restrictive strategy (transfusions initiated at ≤7 g per deciliter). The primary outcome was an unfavorable outcome as assessed by the score on the Glasgow Outcome Scale-Extended at 6 months, which we categorized with the use of a sliding dichotomy that was based on the prognosis of each patient at baseline. Secondary outcomes included mortality, functional independence, quality of life, and depression at 6 months.ResultsA total of 742 patients underwent randomization, with 371 assigned to each group. The analysis of the primary outcome included 722 patients. The median hemoglobin level in the intensive care unit was 10.8 g per deciliter in the group assigned to the liberal strategy and 8.8 g per deciliter in the group assigned to the restrictive strategy. An unfavorable outcome occurred in 249 of 364 patients (68.4%) in the liberal-strategy group and in 263 of 358 (73.5%) in the restrictive-strategy group (adjusted absolute difference, restrictive strategy vs. liberal strategy, 5.4 percentage points; 95% confidence interval, -2.9 to 13.7). Among survivors, a liberal strategy was associated with higher scores on some but not all the scales assessing functional independence and quality of life. No association was observed between the transfusion strategy and mortality or depression. Venous thromboembolic events occurred in 8.4% of the patients in each group, and acute respiratory distress syndrome occurred in 3.3% and 0.8% of patients in the liberal-strategy and restrictive-strategy groups, respectively.ConclusionsIn critically ill patients with traumatic brain injury and anemia, a liberal transfusion strategy did not reduce the risk of an unfavorable neurologic outcome at 6 months. (Funded by the Canadian Institutes of Health Research and others; HEMOTION ClinicalTrials.gov number, NCT03260478.).Copyright © 2024 Massachusetts Medical Society.
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