对急性上部胃肠道出血 (TRIGGER) 的限制性或自由性输血:一个务实的,开放的,集群随机的可行性试验
Vipul Jairath1, Brennan C Kahan2, Alasdair Gray3
1NHS Blood and Transplant, Oxford, UK; Translational Gastroenterology Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
一项多中心试验发现,对于急性上部胃肠道出血,限制性红细胞 (RBC) 输血策略是可行的. 这种方法,具有较低的血红蛋白值,显示了减少红细胞使用的潜力,对于未来的大规模疗效研究至关重要.
科学领域:
- 胃肠病学和肝病学
- 血液学和输血医学 血液学和输血医学
- 临床试验设计和方法论
背景情况:
- 对急性上部胃肠道出血 (UGIB) 的输血门缺乏共识,从小型研究中获得的证据有限.
- 一个单中心试验表明,在UGIB中,限制性红细胞 (RBC) 输血降低了死亡率.
- 一个多中心的可行性,集群随机试验来证实这些发现之前没有评估.
研究的目的:
- 评估多中心,集群随机试验的可行性,以评估在急性UGIB中限制性与自由的红细胞输血策略.
- 收集关于招募,协议遵守和临床结果的数据,以告知更大规模的第三期试验的设计.
主要方法:
- 一个务实的,开放的,集群随机可行性试验,在英国六所大学医院进行.
- 根据医院分配,18岁以上急性UGIB患者被分配到限制性 (Hb <80 g/L) 或自由的 (Hb <100 g/L) 红细胞输血政策中.
- 可行性结局包括招募率,协议遵守和红细胞暴露;临床结局是再出血和28天死亡率.
主要成果:
- 936名患者被录取;在自由政策小组中,招募率更高 (62%对55%,p=0·04).
- 限制性组的协议遵守率更高 (96%与83%相比,p=0·005).
- 在限制性组中输血的红细胞较少 (33%对46%,p=0·23),尽管在统计学上不显著;在临床结果中没有显著差异.
结论:
- 一个集群随机设计是可行的研究输血策略在急性UGIB,使得快速招募和高协议遵守.
- 该研究表明,随着限制性政策的实施,贫血水平的分离以及红细胞输血的非显著减少.
- 在改变临床实践指南之前,必须进行大规模的集群随机试验,以最终评估输血策略的有效性.
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