Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Department of Surgery, Center for Injury Science, University of Alabama at Birmingham, 1808 7th Ave S, Birmingham, AL, 35294, USA.
Trials. 2022 May 12;23(1):384. doi: 10.1186/s13063-022-06346-1.
Haemorrhage is the most common cause of preventable death after injury. REBOA is a novel technique whereby a percutaneously inserted balloon is deployed in the aorta, providing a relatively quick means of temporarily controlling haemorrhage and augmenting cerebral and coronary perfusion, until definitive control of haemorrhage can be attained. The aim of the UK-REBOA trial is to establish the clinical and cost-effectiveness of a policy of standard major trauma centre treatment plus REBOA, as compared with standard major trauma centre treatment alone, for the management of uncontrolled torso haemorrhage caused by injury.
Pragmatic, Bayesian, group-sequential, randomised controlled trial, performed in 16 major trauma centres in England. We aim to randomise 120 injured patients with suspected exsanguinating haemorrhage to either standard major trauma centre care plus REBOA or standard major trauma centre care alone. The primary clinical outcome is 90-day mortality. Secondary clinical outcomes include 3-h, 6-h, and 24-h mortality; in-hospital mortality; 6-month mortality; length of stay (in hospital and intensive care unit); 24-h blood product use; need for haemorrhage control procedure (operation or angioembolisation); and time to commencement of haemorrhage control procedure (REBOA, operation, or angioembolisation). The primary economic outcome is lifetime incremental cost per QALY gained, from a health and personal social services perspective.
This study, which is the first to randomly allocate patients to treatment with REBOA or standard care, will contribute high-level evidence on the clinical and cost-effectiveness of REBOA in the management of trauma patients with exsanguinating haemorrhage and will provide important data on the feasibility of implementation of REBOA into mainstream clinical practice.
ISRCTN16184981.
出血是创伤后最常见的可预防死亡原因。REBOA 是一种新的技术，通过在主动脉内插入一个经皮球囊，提供一种相对快速的方法来暂时控制出血并增加脑和冠状动脉灌注，直到可以获得出血的确定性控制。英国 REBOA 试验的目的是确定标准大型创伤中心治疗加 REBOA 与单独标准大型创伤中心治疗相比，在治疗由创伤引起的不可控制的躯干出血方面的临床和成本效益。
在英格兰的 16 个主要创伤中心进行实用、贝叶斯、分组序贯、随机对照试验。我们的目标是将 120 名疑似出血性出血的受伤患者随机分为标准大型创伤中心治疗加 REBOA 组或单独标准大型创伤中心治疗组。主要临床结局是 90 天死亡率。次要临床结局包括 3 小时、6 小时和 24 小时死亡率；住院死亡率；6 个月死亡率；住院时间（住院和重症监护病房）；24 小时血液制品使用量；需要出血控制程序（手术或血管栓塞）；以及开始出血控制程序的时间（REBOA、手术或血管栓塞）。主要经济结局是从健康和个人社会服务角度获得的每 QALY 的终生增量成本。
这项研究是首次随机分配患者接受 REBOA 或标准治疗，将提供关于 REBOA 在治疗出血性创伤患者中的临床和成本效益的高级别证据，并提供关于将 REBOA 纳入主流临床实践的可行性的重要数据。
ISRCTN85561627。
