Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage

Abstract

ImportanceBleeding is the most common cause of preventable death after trauma.ObjectiveTo 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 ParticipantsPragmatic, 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.InterventionPatients 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 MeasuresThe 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.ResultsOf 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 RelevanceIn 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 Registrationisrctn.org Identifier: ISRCTN16184981

Resuscitative Endovascular Balloon Occlusion of the Aorta in Patients With Exsanguinating Hemorrhage

“…To the Editor A recent randomized clinical trial on REBOA showed that use of the technique may be detrimental to patients in some major trauma centers in the UK. However, I have some concerns about this study.…”

“…However, in this study, balloon dilation was performed in only 19 of 46 patients (41%) making it difficult to examine its true effect on complications. REBOA insertion may have delayed standard care because the time to a definitive hemorrhage control procedure was longer in the REBOA and standard care group vs the standard care alone group …”

“…I am concerned that this study may discourage the use of REBOA in trauma patients. Although REBOA is not a hemostatic technique, it may serve as a temporizing measure before a definitive procedure can be performed to control hemorrhage.…”

Resuscitative Endovascular Balloon Occlusion of the Aorta in Patients With Exsanguinating Hemorrhage—Reply

“…In Reply We thank the authors for the letters about our recently published randomized clinical trial of emergency department REBOA in trauma patients …”

Blood, Bleeding, and Transfusion—A Theme Issue

“…In another original report, Jansen and colleagues tested an approach to limit uncontrolled hemorrhage in trauma: temporary aortic occlusion with the resuscitative endovascular balloon (REBOA). Amidst position statements and observational studies, the authors successfully performed the first randomized trial in humans of REBOA in traumatic injury.…”