The UK resuscitative endovascular balloon occlusion of the aorta in trauma patients with life-threatening torso haemorrhage: the (UK-REBOA) multicentre RCT

Jansen, Jan O and Hudson, Jemma and Kennedy, Charlotte and Cochran, Claire and MacLennan, Graeme and Gillies, Katie and Lendrum, Robbie and Sadek, Samy and Boyers, Dwayne and Ferry, Gillian and Lawrie, Louisa and Nath, Mintu and Cotton, Seonaidh and Wileman, Samantha and Forrest, Mark and Brohi, Karim and Harris, Tim and Lecky, Fiona and Moran, Chris and Morrison, Jonathan J and Norrie, John and Paterson, Alan and Tai, Nigel and Welch, Nick and Campbell, Marion K (2024) The UK resuscitative endovascular balloon occlusion of the aorta in trauma patients with life-threatening torso haemorrhage: the (UK-REBOA) multicentre RCT. Health Technology Assessment, 28 (54). pp. 1-122. ISSN 2046-4924 (https://doi.org/10.3310/ltyv4082)

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Abstract

Background The most common cause of preventable death after injury is haemorrhage. Resuscitative endovascular balloon occlusion of the aorta is intended to provide earlier, temporary haemorrhage control, to facilitate transfer to an operating theatre or interventional radiology suite for definitive haemostasis. Objective To compare standard care plus resuscitative endovascular balloon occlusion of the aorta versus standard care in patients with exsanguinating haemorrhage in the emergency department. Design Pragmatic, multicentre, Bayesian, group-sequential, registry-enabled, open-label, parallel-group randomised controlled trial to determine the clinical and cost-effectiveness of standard care plus resuscitative endovascular balloon occlusion of the aorta, compared to standard care alone. Setting United Kingdom Major Trauma Centres. Participants Trauma patients aged 16 years or older with confirmed or suspected life-threatening torso haemorrhage deemed amenable to adjunctive treatment with resuscitative endovascular balloon occlusion of the aorta. Interventions Participants were randomly assigned 1 : 1 to: standard care, as expected in a major trauma centre standard care plus resuscitative endovascular balloon occlusion of the aorta. Main outcome measures Primary: Mortality at 90 days. Secondary: Mortality at 6 months, while in hospital, and within 24, 6 and 3 hours; need for haemorrhage control procedures, time to commencement of haemorrhage procedure, complications, length of stay (hospital and intensive care unit-free days), blood product use. Health economic: Expected United Kingdom National Health Service perspective costs, life-years and quality-adjusted life-years, modelled over a lifetime horizon. Data sources Case report forms, Trauma Audit and Research Network registry, NHS Digital (Hospital Episode Statistics and Office of National Statistics data). Results Ninety patients were enrolled: 46 were randomised to standard care plus resuscitative endovascular balloon occlusion of the aorta and 44 to standard care. Mortality at 90 days was higher in the standard care plus resuscitative endovascular balloon occlusion of the aorta group (54%) compared to the standard care group (42%). The odds ratio was 1.58 (95% credible interval 0.72 to 3.52). The posterior probability of an odds ratio > 1 (indicating increased odds of death with resuscitative endovascular balloon occlusion of the aorta) was 86.9%. The overall effect did not change when an enthusiastic prior was used or when the estimate was adjusted for baseline characteristics. For the secondary outcomes (3, 6 and 24 hours mortality), the posterior probability that standard care plus resuscitative endovascular balloon occlusion of the aorta was harmful was higher than for the primary outcome. Additional analyses to account for intercurrent events did not change the direction of the estimate for mortality at any time point. Death due to haemorrhage was more common in the standard care plus resuscitative endovascular balloon occlusion of the aorta group than in the standard care group. There were no serious adverse device effects. Resuscitative endovascular balloon occlusion of the aorta is less costly (probability 99%), due to the competing mortality risk but also substantially less effective in terms of lifetime quality-adjusted life-years (probability 91%). Limitations The size of the study reflects the relative infrequency of exsanguinating traumatic haemorrhage in the United Kingdom. There were some baseline imbalances between groups, but adjusted analyses had little effect on the estimates. Conclusions This is the first randomised trial of the addition of resuscitative endovascular balloon occlusion of the aorta to standard care in the management of exsanguinating haemorrhage. All the analyses suggest that a strategy of standard care plus resuscitative endovascular balloon occlusion of the aorta is potentially harmful. Future work The role (if any) of resuscitative endovascular balloon occlusion of the aorta in the pre-hospital setting remains unclear. Further research to clarify its potential (or not) may be required. Trial registration This trial is registered as ISRCTN16184981. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/199/09) and is published in full in Health Technology Assessment; Vol. 28, No. 54. See the NIHR Funding and Awards website for further award information.

ORCID iDs

Jansen, Jan O, Hudson, Jemma, Kennedy, Charlotte, Cochran, Claire, MacLennan, Graeme, Gillies, Katie, Lendrum, Robbie, Sadek, Samy, Boyers, Dwayne, Ferry, Gillian, Lawrie, Louisa, Nath, Mintu, Cotton, Seonaidh, Wileman, Samantha, Forrest, Mark, Brohi, Karim, Harris, Tim, Lecky, Fiona, Moran, Chris, Morrison, Jonathan J, Norrie, John, Paterson, Alan ORCID logoORCID: https://orcid.org/0000-0001-5885-0743, Tai, Nigel, Welch, Nick and Campbell, Marion K;
  • Item type:Article
    ID code:90617
    Dates:
    Date
    Event
    1 September 2024
    Published
    September 2024
    Published Online
    1 September 2024
    Accepted
    Notes:Copyright © 2024 Jansen et al. This work was produced by Jansen et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.
    Subjects:Medicine > Surgery
    Medicine > Internal medicine
    Department:Faculty of Humanities and Social Sciences (HaSS) > Strathclyde Law School > Law
    Depositing user: Pure Administrator
    Date deposited:20 Sep 2024 14:19
    Last modified:19 Nov 2024 01:20
    URI:https://strathprints.strath.ac.uk/id/eprint/90617
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