The UK Resuscitative Endovascular Balloon Occlusion of the Aorta (UK-REBOA) Study

Each year around 5800 people in the United Kingdom die after being severely injured One reason that these patients die is because they have suffered from massive internal bleeding (for example, into their abdomen) If a way was found to stop this bleeding, lives could be saved A new treatment has been developed that could help it is called REBOA REBOA stands for "Resuscitative Endovascular Balloon Occlusion of the Aorta" and 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 trauma surgeons time to operate and stop the bleeding and repair the organs 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 REBOA has not yet been widely used because it is new, complicated to learn and we are not certain how safe and effective it is There have been only three studies published that have compared 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 In 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 The aim of this project is to conduct such an evaluation, to determine whether it is better or worse to use REBOA, in Major Trauma Centres in England When severely injured patients arrive at the Major Trauma Centre, they will be allocated to either receive standard trauma care plus REBOA or standard trauma care alone Patients will be allocated in a fair and balanced way We expect to involve approximately 120 patients in this study, across at least 10 Major Trauma Centres, over three years We will measure a range of outcomes for each patient and whether the patient died or survived This information will be stored centrally, in a national database We will then compare the outcomes to see if the addition of REBOA led to more patients surviving We will also compare the costs We have brought together a team of national experts to undertake this research The team involves surgeons, accident and emergency doctors, anaesthetists, intensive care doctors, together with experts in running and analysing such studies (clinical trialists, statisticians and health economists) We also have patient and public representatives on the team making sure the study is designed well from the patient perspective