TY - JOUR
T1 - Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients with Exsanguinating Hemorrhage
T2 - The UK-REBOA Randomized Clinical Trial
AU - Jansen, Jan O.
AU - Hudson, Jemma
AU - Cochran, Claire
AU - Maclennan, Graeme
AU - Lendrum, Robbie
AU - Sadek, Sam
AU - Gillies, Katie
AU - Cotton, Seonaidh
AU - Kennedy, Charlotte
AU - Boyers, Dwayne
AU - Ferry, Gillian
AU - Lawrie, Louisa
AU - Nath, Mintu
AU - Wileman, Samantha
AU - Forrest, Mark
AU - Brohi, Karim
AU - Harris, Tim
AU - Lecky, Fiona
AU - Moran, Chris
AU - Morrison, Jonathan J.
AU - Norrie, John
AU - Paterson, Alan
AU - Tai, Nigel
AU - Welch, Nick
AU - Campbell, Marion K.
AU - Aylwin, Chris
AU - Bew, Duncan
AU - Brooks, Adam
AU - Chinery, James
AU - Cowlam, Tom
AU - Frith, Dan
AU - George, Arun
AU - Hudson, Anthony
AU - Johnstone, Phillip
AU - Mahmood, Ansar
AU - Novak, Alex
AU - O'Meara, Matt
AU - Reid, Stuart
AU - Sattout, Abdo
AU - Smith, Chris
AU - Stansfield, Tim
AU - Thompson, Julian
N1 - Publisher Copyright:
© 2023 American Medical Association. All rights reserved.
PY - 2023/11/21
Y1 - 2023/11/21
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85175734865&partnerID=8YFLogxK
U2 - 10.1001/jama.2023.20850
DO - 10.1001/jama.2023.20850
M3 - Article
C2 - 37824132
AN - SCOPUS:85175734865
SN - 0098-7484
VL - 330
SP - 1862
EP - 1871
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 19
ER -