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

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.

Trial registration: ClinicalTrials.gov NCT06312436.

Keywords: aortic occlusion; bleeding; noncompressible hemorrhage; trauma.