UK REBOA Study
Research type
Research Study
Full title
A randomised controlled trial of the effectiveness, and cost-effectiveness, of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for trauma.
IRAS ID
226135
Contact name
Jan Jansen
Contact email
Sponsor organisation
University of Aberdeen
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
In the UK around 5800 people die annually after being severely injured. One reason these patients die is because they have suffered from massive internal bleeding. If a way was found to stop this bleeding, lives could be saved.\n\nA new treatment has been developed that could help – it is called “REBOA”(Resuscitative Endovascular Balloon Occlusion of the Aorta). REBOA involves doctors inserting a small balloon directly into the patient’s main artery and inflating it. The balloon then blocks the artery,temporarily stopping the blood flow. Stopping the blood flow in this way gives doctors time to operate. It also helps to keep blood circulating to the brain and heart. However, the parts of the body below the balloon are cut off from the normal blood flow and this may result in short- or longer-term problems.\nREBOA has not been widely used because it is new, complicated to learn and we are not certain how safe and effective it is. Only three studies have been published comparing the results of patients who have received REBOA against those who did not, and results are conflicting –two studies showed REBOA was better, the other that it was worse.\n\nIn England, severely injured patients are treated in Major Trauma Centres. One Major Trauma Centre in London has now introduced REBOA and many other UK hospitals are also interested in using this technique. It is therefore important that we try to evaluate whether it is better or worse to use REBOA before it is adopted more widely into the NHS.\n\nThe aim of this study is to establish, via a randomised controlled trial, the clinical and cost-effectiveness of standard major trauma centre treatment plus REBOA, compared with standard major trauma centre treatment alone, for the management of life-threatening torso haemorrhage in UK major trauma centres.
Summary of Results
Trauma (physical injury) is a major cause of death and disability. The most common cause of preventable death after injury is uncontrolled bleeding. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is a technique whereby a small balloon is inflated in the aorta (main blood vessel) which aims to limit blood loss until an operation can be done to stop the bleeding.In this study, which is the first randomised trial in the world of this technique, we investigated whether adding REBOA to the standard care received in a major trauma centre reduced the risk of death in trauma patients who had life-threatening uncontrolled bleeding.
The study took place in 16 major trauma centres in the UK. Ninety adult trauma patients with confirmed or suspected uncontrolled bleeding took part and were randomly divided into two groups: (1) those who received standard care and (2) those who received standard care plus REBOA. We followed participants for six months using routinely collected data from the NHS and from the Trauma Audit Research Network registry. We also contacted surviving patients at six months to ask about their quality of life.
In the standard care group, 42% of participants died within 90 days of their injury compared to 54% of participants in the standard care plus REBOA group. Risk of death was also higher in the standard care plus REBOA group at all other time-points (3, 6 and 24 hours, in hospital and at 6 months). Overall, the study showed that the use of REBOA in hospital increased the risk of death.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0352
Date of REC Opinion
26 Jun 2017
REC opinion
Favourable Opinion