BACKGROUND: Haemorrhage is the most common cause of preventable death after injury. REBOA is a novel technique whereby a percutaneously inserted balloon is deployed in the aorta, providing a relatively quick means of temporarily controlling haemorrhage and augmenting cerebral and coronary perfusion, until definitive control of haemorrhage can be attained. The aim of the UK-REBOA trial is to establish the clinical and cost-effectiveness of a policy of standard major trauma centre treatment plus REBOA, as compared with standard major trauma centre treatment alone, for the management of uncontrolled torso haemorrhage caused by injury.
METHODS: Pragmatic, Bayesian, group-sequential, randomised controlled trial, performed in 16 major trauma centres in England. We aim to randomise 120 injured patients with suspected exsanguinating haemorrhage to either standard major trauma centre care plus REBOA or standard major trauma centre care alone. The primary clinical outcome is 90-day mortality. Secondary clinical outcomes include 3-h, 6-h, and 24-h mortality; in-hospital mortality; 6-month mortality; length of stay (in hospital and intensive care unit); 24-h blood product use; need for haemorrhage control procedure (operation or angioembolisation); and time to commencement of haemorrhage control procedure (REBOA, operation, or angioembolisation). The primary economic outcome is lifetime incremental cost per QALY gained, from a health and personal social services perspective.
DISCUSSION: This study, which is the first to randomly allocate patients to treatment with REBOA or standard care, will contribute high-level evidence on the clinical and cost-effectiveness of REBOA in the management of trauma patients with exsanguinating haemorrhage and will provide important data on the feasibility of implementation of REBOA into mainstream clinical practice.
The UK-REBOA trial grantholders include Jan O. Jansen, University of Aberdeen, UK, and University of Alabama at Birmingham, USA; Marion K. Campbell, University of Aberdeen, UK; Chris Moran, Nottingham University Hospital Trust, UK; Karim Brohi, Queen Mary University of London, UK; Fiona Lecky, University of Sheffield, UK; Robbie Lendrum, Bart’s Health NHS Trust, UK; Graeme MacLennan, University of Aberdeen, UK; Jonathan J. Morrison, University of Maryland, USA; Nigel Tai, Academic Department of Military Surgery and Trauma, Royal Centre for Defence Medicine, UK; Tim Harris, Bart’s Health NHS Trust, UK; John Norrie, University of Edinburgh, UK; Dwayne Boyers, University of Aberdeen, UK; Alan Paterson, University of Strathclyde, UK; and Nick Welch.
This study/project is funded by the National Institute for Health Research (NIHR) HTA Programme (reference 14/199/09). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funder has/had no role in the design of the study; the collection, analysis, and interpretation of data; or writing the manuscript.
The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.
- Resuscitative endovascular balloon occlusion of the aorta
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Data from: The effectiveness and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma patients with uncontrolled torso haemorrhage: study protocol for a randomised clinical trial (the UK-REBOA trial)
Jansen, J. O. (Creator), Cochran, C. (Creator), Boyers, D. (Creator), Gillies, K. (Creator), Lendrum, R. (Creator), Sadek, S. (Creator), Lecky, F. (Creator), MacLennan, G. (Creator) & Campbell, M. K. (Creator), Figshare, 2022