The UK Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) Randomized Clinical Trial (the UK-REBOA trial): Study Protocol

Abstract BackgroundHaemorrhage 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 definite 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/DesignPragmatic, Bayesian, group-sequential, randomised controlled trial, performed in 16 major trauma centres in England. We aim to randomize 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 3h, 6h, and 24h mortality, in-hospital mortality, 6-month mortality, length of stay (in hospital and intensive care unit), 24h 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.DiscussionThis 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.Trial registrationISRCTN16184981