Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial

Health Services Research Unit, University of Aberdeen, Aberdeen, Scotland. Center for Injury Science, University of Alabama at Birmingham. Barts Health NHS Trust, Royal London Hospital, St Bartholomew's Hospital, London, England. Royal London Hospital, London, England. Health Economics Research Unit, University of Aberdeen, Aberdeen, Scotland. Medical Statistics Team, University of Aberdeen, Aberdeen, Scotland. Queen Mary University of London, London, England. Centre for Urgent and Emergency Care Research, Health Services Research Section, School of Health and Related Research, University of Sheffield, Sheffield, England. Nottingham University Hospital Trust, Nottingham, England. Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minnesota. Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, Scotland. University of Strathclyde, Glasgow, Scotland. Academic Department of Military Surgery and Trauma, Royal Centre for Defence Medicine, Birmingham, England. Patient and public involvement representative in England. St Mary's Hospital, London, England. King's College Hospital, London, England. Queen's Medical Centre, Nottingham, England. University Hospitals of North Midlands, Stoke-on-Trent, England. Hull University Teaching Hospitals, Hull, England. University Hospital, Coventry, England. St George's University Hospital, London, England. Royal Victoria Infirmary, Newcastle upon Tyne, England. Queen Elizabeth Hospital, Birmingham, England. John Radcliffe Hospital, Oxford, England. Sheffield Teaching Hospital, Sheffield, England. Aintree University Hospital, Liverpool, England. James Cook University Hospital, Middlesbrough, England. Leeds General Infirmary, Leeds, England. Southmead Hospital, Bristol, England.

Jama. 2023

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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.
Study details
Language : eng
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