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. 2023 Nov 21;330(19):1862-1871.
doi: 10.1001/jama.2023.20850.

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

Jan O Jansen  1   2 , Jemma Hudson  1 , Claire Cochran  1 , Graeme MacLennan  1 , Robbie Lendrum  3 , Sam Sadek  4 , Katie Gillies  1 , Seonaidh Cotton  1 , Charlotte Kennedy  5 , Dwayne Boyers  5 , Gillian Ferry  1 , Louisa Lawrie  1 , Mintu Nath  6 , Samantha Wileman  1 , Mark Forrest  1 , Karim Brohi  7 , Tim Harris  3 , Fiona Lecky  8 , Chris Moran  9 , Jonathan J Morrison  10 , John Norrie  11 , Alan Paterson  12 , Nigel Tai  13 , Nick Welch  14 , Marion K Campbell  1 ; UK-REBOA Study Group; Chris Aylwin  15 , Duncan Bew  16 , Adam Brooks  17 , James Chinery  18 , Tom Cowlam  19 , Dan Frith  15 , Arun George  20 , Anthony Hudson  21 , Phillip Johnstone  22 , Ansar Mahmood  23 , Alex Novak  24 , Matt O'Meara  18 , Stuart Reid  25 , Abdo Sattout  26 , Chris Smith  27 , Tim Stansfield  28 , Julian Thompson  29
Affiliations

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

Jan O Jansen et al. JAMA. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Jansen reported receiving personal fees from CSL Behring, Cellphire, and Infrascan and receiving grants from CSL Behring, Infrascan, and RevMedX. Dr Lendrum reported serving as a medical advisory board member for Certus Critical Care. Dr Gillies reported receiving study support from the Intuitive Surgical European Research Board. Dr Lecky reported receiving grants from the Trauma Audit and Research Network. Dr Morrison reported being a member of the clinical advisory board and holding stock options in Prytime Medical. Mr Tai reported being employed by the UK Ministry of Defense and receiving grants from the US Department of Defense. Dr Campbell reported receiving study support from the Intuitive Surgical European Research Board. Dr Novak reported receiving personal fees from GE Healthcare. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Recruitment, Randomization, and Patient Flow in the UK-REBOA Trial
REBOA indicates resuscitative endovascular balloon occlusion of the aorta; UK-REBOA, UK Resuscitative Endovascular Balloon Occlusion of the Aorta. aTrauma patients aged 16 years or older were eligible for inclusion in this trial. Patients deemed ineligible for the REBOA intervention were excluded prior to randomization.
Figure 2.
Figure 2.. Primary Outcome and Kaplan-Meier Survival Estimates
REBOA indicates resuscitative endovascular balloon occlusion of the aorta.
See this image and copyright information in PMC

Comment in

References

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