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.
TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN16184981.
| Original language | English |
|---|---|
| Pages (from-to) | 1862-1871 |
| Number of pages | 10 |
| Journal | JAMA |
| Volume | 330 |
| Issue number | 19 |
| Early online date | 12 Oct 2023 |
| DOIs | |
| Publication status | Published - 21 Nov 2023 |
Bibliographical note
Funding/Support: This research (project No. 14/199/09) was funded by the National Institute for Health and Care Research Health Technology Assessment Programme. The Health Services Research Unit and the Health Economics Research Unit are funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorate.Data Availability Statement
Data will be made available for sharing on request.How to access data: Requests for access should be addressed to the corresponding author and will be considered by the study team.
Keywords
- Adult
- Aorta
- Balloon Occlusion/adverse effects
- Bayes Theorem
- Emergency Service, Hospital
- Exsanguination/complications
- Female
- Hemorrhage/etiology
- Humans
- Injury Severity Score
- Male
- Resuscitation/methods
- Retrospective Studies
- United Kingdom
