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期刊来源：JAMA

文献发表时间：2023-10-12

原文链接：https://jamanetwork.com/journals/jama/article-abstract/2810757

关键点内容如下：

问题

关键点问题在标准治疗的基础上增加主动脉复苏性血管内球囊阻断术（REBOA）是否能降低创伤出血患者的死亡率？

调查结果

在这项90天时纳入89名患者的贝叶斯随机临床试验中，REBOA和标准治疗组的全因死亡率为54%，而单纯标准治疗组为42%（比值比为1.58；REBOA死亡率增加的后验概率为86.9%）。

意义

在伴有放血性出血的创伤患者中，REBOA和急诊科的标准护理策略与单独的标准护理相比，并不会降低死亡率，反而可能会增加死亡率。摘要内容如下：

重要性

出血是创伤后可预防死亡的最常见原因。

目的

确定在急诊科与标准护理一起使用的主动脉血管内球囊阻断术（REBOA）与单独使用标准护理相比，对伴有失血性出血的创伤患者死亡率的有效性。

研究设计和参与者

在英国16个主要创伤中心进行的实用、贝叶斯、随机临床试验。在2017年10月至2022年3月期间纳入16岁或以上的失血性出血患者，并随访90天。

干预

患者被随机分配（1:1分配）到包括REBOA和标准治疗（n=46）或单独标准治疗（n=44）的策略中。

主要结局和措施

主要转归是90天时的全因死亡率。10个次要转归包括6个月时、住院期间、24小时内、6小时内或3小时内的死亡率；需要明确的出血控制程序；确定性出血控制程序开始的时间；并发症；住院时间；血液制品使用；和死亡原因结果。

结果

在90名（患者中，中位年龄为41岁[IQR，31-59岁]；男性62例，占69%；损伤严重程度评分的中位数为41[IQR，29-50]）随机分组，89名患者被纳入主要结果分析，因为单独标准治疗组中有1名患者在入组后4天拒绝同意继续参与和收集数据。90天时，在REBOA和标准治疗组中，46名患者中有25名（54%的）发生了全因死亡，而在单纯标准治疗组中，43名患者中有18名（42%的）（比值比[OR]，1.58[95%可信区间，0.72-3.52]；OR>1的后验概率[表明REBOA死亡几率增加]，86.9%）。在10个次要终点中，在REBOA和标准护理组中，死亡率的OR值和6个月、住院、24小时、6小时或3小时死亡率的OR值大于1的后验概率均增加，并且OR值随着较早的死亡终点而增加。REBOA和标准护理组（25例患者中有8例[32%]）因出血死亡的人数多于单纯标准护理组（18例患者中有3例[17%]），且大多数发生在24小时内。

结论和相关性

在伴有放血性出血的创伤患者中，与单独的标准护理相比，急诊科的REBOA和标准护理策略不会降低死亡率，反而可能会增加死亡率。

英文原文如下：

Key Points

Question  Does the addition of resuscitative endovascular balloon occlusion of the aorta (REBOA) to standard care reduce mortality in trauma patients with exsanguinating hemorrhage?

Findings  In this bayesian randomized clinical trial that included 89 patients at 90 days, all-cause mortality was 54% in the REBOA and standard care group vs 42% in the standard care alone group (odds ratio, 1.58; posterior probability of increased odds of death with REBOA, 86.9%).

Meaning  In trauma patients with exsanguinating hemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase mortality compared with standard care alone.

Abstract

Importance  Bleeding is the most common cause of preventable death after trauma.

Objective  To determine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) when used in the emergency department along with standard care vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage.

Design, Setting, and Participants  Pragmatic, bayesian, randomized clinical trial conducted at 16 major trauma centers in the UK. Patients aged 16 years or older with exsanguinating hemorrhage were enrolled between October 2017 and March 2022 and followed up for 90 days.

Intervention  Patients were randomly assigned (1:1 allocation) to a strategy that included REBOA and standard care (n = 46) or standard care alone (n = 44).

Main Outcomes and Measures  The primary outcome was all-cause mortality at 90 days. Ten secondary outcomes included mortality at 6 months, while in the hospital, and within 24 hours, 6 hours, or 3 hours; the need for definitive hemorrhage control procedures; time to commencement of definitive hemorrhage control procedures; complications; length of stay; blood product use; and cause of death.

Results  Of the 90 patients (median age, 41 years [IQR, 31-59 years]; 62 [69%] were male; and the median Injury Severity Score was 41 [IQR, 29-50]) randomized, 89 were included in the primary outcome analysis because 1 patient in the standard care alone group declined to provide consent for continued participation and data collection 4 days after enrollment. At 90 days, 25 of 46 patients (54%) had experienced all-cause mortality in the REBOA and standard care group vs 18 of 43 patients (42%) in the standard care alone group (odds ratio [OR], 1.58 [95% credible interval, 0.72-3.52]; posterior probability of an OR >1 [indicating increased odds of death with REBOA], 86.9%). Among the 10 secondary outcomes, the ORs for mortality and the posterior probabilities of an OR greater than 1 for 6-month, in-hospital, and 24-, 6-, or 3-hour mortality were all increased in the REBOA and standard care group, and the ORs were increased with earlier mortality end points. There were more deaths due to bleeding in the REBOA and standard care group (8 of 25 patients [32%]) than in standard care alone group (3 of 18 patients [17%]), and most occurred within 24 hours.

Conclusions and Relevance  In trauma patients with exsanguinating hemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase, mortality compared with standard care alone.

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