研究动态
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高危癌症手术后输血血红蛋白阈值和功能恢复:一项随机对照试验的初步研究。

Postoperative transfusion hemoglobin threshold and functional recovery after high-risk oncologic surgery: A randomized controlled pilot study.

发表日期:2023 Apr 27
作者: Xavier Chapalain, Sigismond Lasocki, Thomas Gargadennec, Maëlys Consigny, Maeva Campfort, Anna Cadic, Maxime Léger, Patricia Dias, Catherine Le Niger, Rosemary L Sparrow, Olivier Huet, Cécile Aubron
来源: Cellular & Molecular Immunology

摘要:

在术后康复可能影响癌症治疗方案的重大肿瘤手术后,缺乏可靠证据以指导最佳输血管理。我们进行了一项研究,验证了在重大肿瘤手术后比较自由和限制性红细胞(RBC)输血策略的更大规模试验的可行性。这是一项在两个中心进行的随机对照研究,研究对象是在重大肿瘤手术后住院进入重症监护室的患者。血红蛋白水平下降到9.5 g/dL以下的患者,被随机分配到立即接受1单位RBC输血(自由)或将输血推迟至血红蛋白水平下降到7.5 g/dL以下(限制性)。主要结果是从随机分组到术后30天内的中位数血红蛋白水平。 WHODAS 2.0问卷评估了无残疾存活。15个月内随机了30名患者(每组15名患者),平均每月招募率为1.8名患者。自由组的中位数血红蛋白水平显著高于限制性组:10.1 g/dL(IQR 9.6-10.5)与8.8 g/dL(IQR 8.3-9.4),p<.001,RBC输血率分别为100%和66.7%,p=.04。两组间的无残疾存活率相似:26.7%和20%,p=1。我们的结果支持进行第3阶段随机对照试验的可行性,以比较自由和限制性输血策略对于重大肿瘤手术后危重病患者的功能恢复的影响。©2023年作者。《输血》由Wiley Periodicals LLC代表AABB发布。
Robust evidence to inform best transfusion management after major oncologic surgery, where postoperative recovery might impact treatment regimens for cancer, is lacking. We conducted a study to validate the feasibility of a larger trial comparing liberal versus restrictive red blood cells (RBC) transfusion strategies after major oncologic surgery.This was a two-center, randomized, controlled, study of patients admitted to the intensive care unit after major oncologic surgery. Patients whose hemoglobin level dropped below 9.5 g/dL, were randomly assigned to immediately receive a 1-unit RBC transfusion (liberal) or delayed until the hemoglobin level dropped below 7.5 g/dL (restrictive). The primary outcome was the median hemoglobin level between randomization to day 30 post-surgery. Disability-free survival was evaluated by the WHODAS 2.0 questionnaire.30 patients were randomized (15 patients/group) in 15 months with a mean recruitment rate of 1.8 patients per month. The median hemoglobin level was significantly higher in the liberal group than in the restrictive group: 10.1 g/dL (IQR 9.6-10.5) versus 8.8 g/dL (IQR 8.3-9.4), p < .001, and RBC transfusion rates were 100% versus 66.7%, p = .04. The disability-free survival was similar between groups: 26.7% versus 20%, p = 1.Our results support the feasibility of a phase 3 randomized controlled trial comparing the impact of liberal versus restrictive transfusion strategies on the functional recovery of critically ill patients following major oncologic surgery.© 2023 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.