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用于治疗出血无法控制的创伤患者的复苏性血管内主动脉球囊阻断术:一项回顾性目标试验模拟研究(AT-REBOA目标试验)

Resuscitative endovascular balloon occlusion of the aorta for trauma patients with uncontrolled hemorrhage: a retrospective target trial emulation (the AT-REBOA target trial).

作者信息

Hallmann Barbara, Honnef Gabriel, Eibinger Nicolas, Eichlseder Michael, Posch Martin, Puchwein Paul, Zoidl Philipp, Zajic Paul

机构信息

Department of Anaesthesiology and Intensive Care Medicine.

Department of Orthopaedics and Trauma Surgery, Medical University Graz, Graz.

出版信息

Eur J Emerg Med. 2025 Jun 1;32(3):202-209. doi: 10.1097/MEJ.0000000000001183. Epub 2024 Sep 24.

Abstract

BACKGROUND

Noncompressible truncal hemorrhage is a major contributor to preventable deaths in trauma patients and, despite advances in emergency care, still poses a big challenge.

OBJECTIVES

This study aimed to assess the clinical efficacy of trauma resuscitation care incorporating Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) compared to standard care for managing uncontrolled torso or lower body hemorrhage.

METHODS

This study utilized a target trial design with a matched case-control methodology, emulating randomized 1 : 1 allocation for patients receiving trauma resuscitation care with or without the use of REBOA. The study was conducted at a high-volume trauma center in Southern Austria, including trauma patients treated between January 2019 and October 2023, aged 16 and above, with suspected severe non-compressible torso hemorrhage. The primary outcome was 30-day in-hospital mortality. Secondary outcomes were in-hospital mortality rates at 3, 6, 24 h, and 90 days, need for damage control procedures, time to these procedures, computed tomography (CT) scan rates during resuscitation, complications, length of intensive care and in-hospital stay, and causes of death.

RESULTS

Median age was 55 [interquartile range (IQR) 42-64] years. Median total injury severity, assessed by Injury Severity Score, was 46.5 (IQR: 43-57). There was no significant difference in 30-day in-hospital mortality between groups [9/22 (41%) vs. 9/22 (41%), odds ratio: 1.00, 95% confidence interval (CI): 0.3-3.36, P  > 0.999]. Lower mortality rates within 3, 6, and 24 h were observed in the REBOA group; in a Cox proportional hazards model, hazard ratio (95% CI) for mortality in the REBOA group was 0.87 (0.35-2.15). Timing to damage control procedures did not significantly differ between groups, although patients in the REBOA group underwent significantly more CT scans. Bleeding was cited as the main cause of death less frequently in the REBOA group.

CONCLUSION

In severely injured patients presenting with possible major non-compressible torso hemorrhage, a systematically implemented resuscitation strategy including REBOA during the initial hospital phase, is not associated with significant changes in mortality.

摘要

背景

不可压缩性躯干出血是创伤患者可预防死亡的主要原因,尽管急诊护理有所进步,但仍然是一个巨大挑战。

目的

本研究旨在评估与标准护理相比,采用主动脉内复苏球囊阻断术(REBOA)的创伤复苏护理对控制无法控制的躯干或下肢出血的临床疗效。

方法

本研究采用目标试验设计和匹配病例对照方法,模拟对接受或未接受REBOA创伤复苏护理的患者进行1∶1随机分配。该研究在奥地利南部一家大型创伤中心进行,纳入2019年1月至2023年10月期间治疗的年龄在16岁及以上、疑似严重不可压缩性躯干出血的创伤患者。主要结局是30天住院死亡率。次要结局包括3、6、24小时和90天的住院死亡率、损伤控制手术的需求、进行这些手术的时间、复苏期间的计算机断层扫描(CT)扫描率、并发症、重症监护和住院时间以及死亡原因。

结果

中位年龄为55岁[四分位间距(IQR)42 - 64岁]。通过损伤严重程度评分评估的中位总损伤严重程度为46.5(IQR:43 - 57)。两组间30天住院死亡率无显著差异[9/22(41%)对9/22(41%),优势比:1.00,95%置信区间(CI):0.3 - 3.36,P>0.999]。REBOA组在3、6和24小时内的死亡率较低;在Cox比例风险模型中,REBOA组的死亡风险比(95%CI)为0.87(0.35 - 2.15)。两组间损伤控制手术的时间无显著差异,尽管REBOA组患者接受CT扫描的次数明显更多。REBOA组将出血列为主要死亡原因的频率较低。

结论

在可能存在严重不可压缩性躯干出血的重伤患者中,在医院初始阶段系统实施包括REBOA的复苏策略与死亡率的显著变化无关。

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