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REBOA fails to reduce mortality, first clinical trial finds

In the first clinical trial on REBOA (Resuscitative endovascular balloon occlusion of the aorta) done in Britain by a team of US scientists, it was found that the strategy did not reduce mortality, and may even have increased 90-day mortality, when added to standard haemorrhagic management.

Haemorrhage is the most common cause of preventable death after trauma, the natural history of uncontrolled bleeding being decreasing cardiac output and hypotension, and ultimately failure of compensatory mechanisms with consequent cerebral and myocardial hypoperfusion leading to death.

In contrast, when haemorrhage is controlled expeditiously, patients often recover, reports Medscape.

Bleeding originating from within the torso is particularly challenging because it cannot be controlled without surgery, and many patients die before they can be taken to an operating room.

Temporary aortic occlusion, which is used to limit haemorrhage and maintain cerebral and myocardial perfusion until definitive control can be obtained, is conceptually attractive.

REBOA is a novel technique whereby a percutaneously inserted balloon is inflated in the aorta. Large animal studies have shown REBOA to be highly effective, but the current evidence for REBOA in injured humans is limited and conflicting.

A position statement from the American College of Emergency Physicians and the American College of Surgeons recommends REBOA for traumatic life-threatening haemorrhage below the diaphragm in patients with haemorrhagic shock who are unresponsive or transiently responsive to resuscitation, and for patients arriving at the hospital in cardiac arrest from trauma due to presumed life-threatening haemorrhage below the diaphragm.

However, until now, there have been no randomised clinical trials.

The aim of the UK Resuscitative Endovascular Balloon Occlusion of the Aorta (UK-REBOA) trial was to examine the effectiveness of REBOA and standard care compared with standard care alone for the management of uncontrolled torso haemorrhage at specialist major trauma centres in the UK.

The trial enrolled 90 patients with confirmed or suspected life-threatening torso haemorrhage who were treated at 16 major trauma centres in the UK; 46 were randomly assigned to receive REBOA and standard care, and 44 were assigned to receive standard care alone.

Summing up

All-cause mortality at 90 days (primary outcome) was 54% in the REBOA group, vs 42% in the standard care group (odds ratio [OR] 1.58; 95% credible interval. 0.72 – 3.52); the posterior probability increased odds of death with REBOA was 86.9%.

Among 10 secondary outcomes, the ORs for mortality and the posterior probabilities of an OR >1 for 6-month and in-hospital mortality, as well as mortality at 3, 6, and 24 hours, were all increased in the REBOA group.

There were more deaths due to bleeding with than without REBOA (8 of 25 patients [32%] vs 3 of 18 patients [17%]); most occurred within 24 hours.

In practice

“REBOA is a challenging and complex procedure to perform, especially in patients who are at imminent risk of dying. The trial clearly did not show the expected benefits but is incredibly important because it will prompt clinicians and trauma centres to re-evaluate whether they should be using REBOA in emergency departments,” said co-chief investigator Jan Jansen, PhD, with the Centre for Injury Science, University of Alabama at Birmingham, US.

The trial was published in JAMA.

Limitations

The small sample size reflects the relative infrequency and etiology of exsanguinating haemorrhage in the UK, where blunt trauma predominates, and most penetrating trauma stems from stabbings rather than gunshot wounds.

The results may therefore not translate to other settings. There were some baseline imbalances between the two groups.

Study details

Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients with Exsanguinating Haemorrhage: The UK-REBOA Randomised Clinical Trial

Jan Jansen,  Jemma Hudson,  Claire Cochran,  et al.

Published in JAMA Network on 12 October 2023

Key Points

Question Does the addition of resuscitative endovascular balloon occlusion of the aorta (REBOA) to standard care reduce mortality in trauma patients with exsanguinating haemorrhage?
Findings In this Bayesian randomised clinical trial that included 89 patients at 90 days, all-cause mortality was 54% in the REBOA and standard care group vs 42% in the standard care alone group (odds ratio, 1.58; posterior probability of increased odds of death with REBOA, 86.9%).
Meaning In trauma patients with exsanguinating haemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase mortality compared with standard care alone.

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 haemorrhage.

Design, Setting, and Participants
Pragmatic, Bayesian, randomised clinical trial conducted at 16 major trauma centres in the UK. Patients aged 16 or older with exsanguinating haemorrhage 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 haemorrhage control procedures; time to commencement of definitive haemorrhage 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]) randomised, 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 enrolment. 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 haemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase, mortality compared with standard care alone.

 

JAMA article – Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients with Exsanguinating Haemorrhage: The UK-REBOA Randomised Clinical Trial (Open access)

 

Medscape article – REBOA Fails to Improve Outcomes in Traumatic Torso Haemorrhage (Open access)

 

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