Uncontrolled bleeding is a leading cause of preventable death following major injury. Military experience has shown that the use of tourniquets improves survival, by stopping bleeding before surgery. However, tourniquets are effective at stopping bleeding from the extremities but are ineffective when the bleeding is inside the torso.

The Trial

REBOA (which stands for Resuscitative Endovascular Balloon Occlusion of the Aorta) is a new technique designed to stop internal haemorrhage. REBOA involves passing a small inflatable balloon into the aorta (the main artery in the body) to stop the bleeding until a patient can be taken to an operating theatre. While REBOA has shown early promise we do not yet know whether it is better than the standard care given to trauma patients. The UK-REBOA trial aims to compare standard major trauma centre care with REBOA versus standard major trauma care alone.

The study has been designed by Chief Investigator Jan Jansen and researchers from Aberdeen University. It has some unique challenges, such as conducting a Randomised Controlled Trial in critically injured patients with an extreme time pressure to intervention. The trial will also only include those patients thought to have exsanguinating (life-threatening) haemorrhage.  Because patients such as these are relatively rare in the UK, Dr Jansen has designed the trial using a Bayesian design which is very different to the majority of clinical trial designs. A Bayesian design allows relatively small numbers of patients to be enrolled in the study while still producing meaningful evidence of the effect of REBOA. The trial expects to involve approximately 120 patients, across 10 Major Trauma Centres, over four years.

The Royal London Hospital Major Trauma centre was the first of these sites to “Go Live”, officially opening as a recruiting site in November 2017. Up until the start of the trial, the Royal London Hospital was the only hospital in the country regularly treating patients that have had a REBOA inserted either by doctors on London’s Air Ambulance or in the Emergency Department of the Hospital.

The trial will measure a range of outcomes for each patient, including survival, with data stored in a national database. In addition to patient outcomes, the trial will also look at the costs of those who received REBOA with those who did not.

A large multi-disciplinary team of clinicians and researchers are involved in caring for these patients and running the trial. The team involves surgeons, emergency medicine doctors, anaesthetists, intensive care doctors, nurses and clinical research fellows. 

More information on the UK-REBOA Trial site

Study leads

Chief Investigator (trial): Jan Jansen

Study lead (Royal London): Dr Samy Sadek

Senior Investigators (C4TS) : Professor Karim Brohi  and Colonel Nigel Tai


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