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Liberal or Restrictive Transfusion Strategy in Aneurysmal Subarachnoid Hemorrhage.
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2024-12-09 , DOI: 10.1056/nejmoa2410962 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,
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2024-12-09 , DOI: 10.1056/nejmoa2410962 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,
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.).
中文翻译:
动脉瘤性蛛网膜下腔出血的自由或限制性输血策略。
背景 与限制性策略相比,自由红细胞输注策略对动脉瘤性蛛网膜下腔出血后重症监护期间患者的影响尚不清楚。方法 我们将患有急性动脉瘤性蛛网膜下腔出血和贫血的危重症成人随机分配到自由策略 (血红蛋白水平为 ≤10 g/分升) 或限制性策略 (血红蛋白水平为 ≤8 g/分升) 的可选输血。主要结局是不良的神经系统结局,定义为 12 个月时改良 Rankin 量表评分 (范围为 0 到 6,评分越高表示残疾程度越高) 得分为 4 分或更高。次要结局包括使用功能独立性测量 (FIM;分数范围为 18 至 126) 评估的 12 个月功能独立性,以及使用 EuroQol 五维、五级 (EQ-5D-5L) 效用指数(分数范围为 -0.1 至 0.95)和视觉模拟量表 (VAS;分数范围为 0 至 100)评估的生活质量;在每次评估中,分数越高表示健康状况或生活质量越好。结果 共有 742 例患者在 23 个中心接受了随机分组。12 个月时的主要结局分析包括 725 例患者 (97.7%)。自由策略组 364 例患者中有 122 例 (33.5%) 发生不良神经系统结局,限制策略组 361 例患者中有 136 例 (37.7%) 发生不良神经系统结局 (风险比,0.88;95% 置信区间 [CI],0.72 至 1.09;P = 0.22)。自由策略组的平均 (±SD) FIM 评分为 82.8±54.6,限制策略组为 79.8±54.5 分 (平均差,3.01;95% CI,-5.49 至 11.51)。两组的平均 EQ-5D-5L 效用指数评分为 0.5±0.4 (平均差,0.02;95% CI,-0.04 到 0.09)。自由策略组的平均 VAS 评分为 52.1±37.5,限制策略组为 50±37.1 (均数差,2.08;95% CI,-3.76 至 7.93)。两组不良事件的发生率相似。结论 在动脉瘤性蛛网膜下腔出血和贫血患者中,与限制性输血策略相比,自由输血策略在 12 个月时出现不良神经系统结局的风险并不低。(由加拿大卫生研究院和其他机构资助;撒哈拉 ClinicalTrials.gov 编号,NCT03309579.)。
更新日期:2024-12-09
中文翻译:
动脉瘤性蛛网膜下腔出血的自由或限制性输血策略。
背景 与限制性策略相比,自由红细胞输注策略对动脉瘤性蛛网膜下腔出血后重症监护期间患者的影响尚不清楚。方法 我们将患有急性动脉瘤性蛛网膜下腔出血和贫血的危重症成人随机分配到自由策略 (血红蛋白水平为 ≤10 g/分升) 或限制性策略 (血红蛋白水平为 ≤8 g/分升) 的可选输血。主要结局是不良的神经系统结局,定义为 12 个月时改良 Rankin 量表评分 (范围为 0 到 6,评分越高表示残疾程度越高) 得分为 4 分或更高。次要结局包括使用功能独立性测量 (FIM;分数范围为 18 至 126) 评估的 12 个月功能独立性,以及使用 EuroQol 五维、五级 (EQ-5D-5L) 效用指数(分数范围为 -0.1 至 0.95)和视觉模拟量表 (VAS;分数范围为 0 至 100)评估的生活质量;在每次评估中,分数越高表示健康状况或生活质量越好。结果 共有 742 例患者在 23 个中心接受了随机分组。12 个月时的主要结局分析包括 725 例患者 (97.7%)。自由策略组 364 例患者中有 122 例 (33.5%) 发生不良神经系统结局,限制策略组 361 例患者中有 136 例 (37.7%) 发生不良神经系统结局 (风险比,0.88;95% 置信区间 [CI],0.72 至 1.09;P = 0.22)。自由策略组的平均 (±SD) FIM 评分为 82.8±54.6,限制策略组为 79.8±54.5 分 (平均差,3.01;95% CI,-5.49 至 11.51)。两组的平均 EQ-5D-5L 效用指数评分为 0.5±0.4 (平均差,0.02;95% CI,-0.04 到 0.09)。自由策略组的平均 VAS 评分为 52.1±37.5,限制策略组为 50±37.1 (均数差,2.08;95% CI,-3.76 至 7.93)。两组不良事件的发生率相似。结论 在动脉瘤性蛛网膜下腔出血和贫血患者中,与限制性输血策略相比,自由输血策略在 12 个月时出现不良神经系统结局的风险并不低。(由加拿大卫生研究院和其他机构资助;撒哈拉 ClinicalTrials.gov 编号,NCT03309579.)。