UK-REBOA

Resuscitative Endovascular Balloon Occlusion of the Aorta in Exsanguinating Trauma

Patient / Population Intervention / Exposition Comparaison Critère de jugement

In 90 trauma patients with exsanguinating torso haemorrhage, emergency-department REBOA plus standard care increased 90-day all-cause mortality compared with standard care alone.

Schéma

Pragmatic, bayesian, group-sequential randomised clinical trial at 16 UK major trauma centres; patients aged 16 years or older with exsanguinating haemorrhage enrolled October 2017 to March 2022 and randomised 1:1 to a strategy including emergency-department REBOA plus standard care or standard care alone, with 90-day follow-up. Stopped early at the second interim analysis (80 patients) when the prespecified harm rule was met (90.1% posterior probability of OR >1). Only 19 of 46 patients assigned to REBOA had a balloon inserted and inflated.

Critère

All-cause mortality at 90 days.

RésultatAll-cause mortality at 90 days occurred in 25 of 46 patients (54%) assigned to REBOA plus standard care vs 18 of 43 (42%) assigned to standard care alone (OR 1.58, 95% credible interval 0.72-3.52; posterior probability of an OR >1 86.9%). Odds ratios for 6-month, in-hospital and 24-, 6- and 3-hour mortality were all increased with REBOA and grew larger at earlier time points; deaths due to bleeding were more frequent with REBOA (8/25, 32%) than with standard care (3/18, 17%). Median time to commencement of definitive haemorrhage-control procedures was 83 vs 64 minutes, and laparotomy was performed in 7 vs 12 patients.

Jansen JO, Hudson J, Cochran C, et al. Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial. JAMA. 2023;330(19):1862-1871. 10.1001/jama.2023.20850