REBOA

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Resuscitative endovascular balloon occlusion of the aorta for trauma

Aim

The REBOA trial aims to establish the clinical and cost-effectiveness of (Resuscitative Endovascular Balloon Occlusion of the Aorta) REBOA, as compared with standard treatment alone, for the management of uncontrolled torso haemorrhage caused by injury, in specialist trauma centres.

Background/method

Annually, in the UK, around 5,800 people die after being severely injured. Many of these patients die due to internal bleeding, therefore, a treatment which addresses this would logically lead to lower mortality rates. A new treatment – REBOA – refers to a procedure where surgeons insert a small balloon directly into the patient’s main artery, which is then inflated. This balloon blocks the artery, temporarily suspending blood flow, and provides the surgeon time to operate. The procedure also helps to keep blood circulating to the brain and heart. However, a caveat of REBOA is that blood flow is restricted to areas below the balloon. Subsequently, this may result in either short term or long term problems for the patient. Thus far, REBOA has not been widely adopted as it is relatively new, technically complicated and the procedure has not yet been proven to be superiorly effective or have a favourable safety profile. 3 studies have been published that compare the results of patients who have received REBOA versus those who did not. These data are conflicting; 2 studies showed REBOA was the superior course of action, while the other paper demonstrated that it was worse. In England, severely injured patients are treated in Major Trauma Centres. One such Centre in London has now introduced REBOA while many other UK hospitals are now interested in using this technique. Henceforth, it is imperative that the questions surrounding the REBOA procedure are answered before it can be more widely practiced in the NHS. The aim of this study is to establish, via a randomised controlled trial, whether the clinical and cost-effectiveness of standard treatment plus REBOA is superior to standard treatment alone in the management of life-threatening torso haemorrhage in UK major trauma centres.

Chief investigator

Chief investigator

Mr Jan Jansen

Principal investigator

Principal investigator

Mr Ansar Mahmood
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Current recruitment number