创伤性脑损伤患者的自由输血策略或限制输血策略。
Liberal or Restrictive Transfusion Strategy in Patients with Traumatic Brain Injury.
机构信息
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.
出版信息
N Engl J Med. 2024 Aug 22;391(8):722-735. doi: 10.1056/NEJMoa2404360. Epub 2024 Jun 13.
BACKGROUND
The effect of a liberal transfusion strategy as compared with a restrictive strategy on outcomes in critically ill patients with traumatic brain injury is unclear.
METHODS
We 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.
RESULTS
A 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.
CONCLUSIONS
In 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.).
背景
在创伤性脑损伤的危重症患者中，与限制性输血策略相比，宽松输血策略对结局的影响尚不清楚。
方法
我们将中度或重度创伤性脑损伤合并贫血的成人患者随机分为两组，分别接受宽松输血策略（血红蛋白水平≤10 g/dL 时开始输血）或限制性输血策略（血红蛋白水平≤7 g/dL 时开始输血）治疗。主要结局是采用扩展格拉斯哥预后评分（Glasgow Outcome Scale-Extended）评估的 6 个月时的不良结局，我们采用基于每个患者基线预后的滑动二分法对此进行分类。次要结局包括 6 个月时的死亡率、功能独立性、生活质量和抑郁。
结果
共有 742 例患者接受了随机分组，每组 371 例。对主要结局的分析纳入了 722 例患者。在接受强化护理的患者中，宽松策略组的平均血红蛋白水平为 10.8 g/dL，限制策略组为 8.8 g/dL。在宽松策略组，364 例患者中有 249 例（68.4%）发生不良结局，在限制策略组，358 例患者中有 263 例（73.5%）发生不良结局（调整后的绝对差异，限制策略组比宽松策略组，5.4 个百分点；95%置信区间，-2.9 至 13.7）。在幸存者中，宽松策略与一些但不是所有评估功能独立性和生活质量的量表得分较高有关。输血策略与死亡率或抑郁之间没有关联。两组患者的静脉血栓栓塞事件发生率均为 8.4%，宽松策略组和限制策略组急性呼吸窘迫综合征的发生率分别为 3.3%和 0.8%。
结论
在创伤性脑损伤合并贫血的危重症患者中，宽松输血策略并未降低 6 个月时不良神经结局的风险。（由加拿大卫生研究院和其他机构资助；HEMOTION ClinicalTrials.gov 注册号：NCT03260478。）
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