Title: The UK Resuscitative Endovascular Balloon Occlusion of the Aorta (UK-REBOA) Study
Funder: Chief Scientist Office, Scotland

Abstract: Design: Bayesian group-sequential randomised controlled trial, led by a UK-wide alliance of clinicians and methodologists, comparing standard major trauma centre (MTC) treatment plus REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) with standard MTC treatment alone, for trauma patients with suspected life-threatening torso haemorrhage (with initial feasibility phase to ensure that enrolment, randomisation and early data collection features are optimised). Setting: MTCs in England. Participants: Adult trauma patients (aged, or believed to be aged, 16 years or older) presenting at MTCs with suspected life-threatening torso haemorrhage. Exclusion criteria: Women known or thought to be pregnant at presentation; injuries deemed clinically unsurvivable. Health technology being assessed: Standard MTC treatment plus REBOA, compared with standard MTC treatment. Primary outcomes: Primary effectiveness outcome: 90-day mortality. Primary economic outcome: Lifetime incremental cost per Quality Adjusted Life Year (QALY) gained, from a health and personal social services perspective. Secondary outcomes: 24-hour mortality, in-hospital mortality. Hospital and intensive care length of stay; 24h blood product use; need for haemorrhage control procedure; time to commencement of haemorrhage control procedure; safety data; procedural performance details; functional outcome and quality of life: EQ-5D-5L and extended Glasgow Outcome Score (GOS-E) at 6 months follow up; secondary economic outcomes: Costs from an NHS and patient and social services perspective (at 6 months); incremental cost per QALY gained at 6 months. Data collection: Data collection will be initiated by clinicians, using a bespoke online mechanism. Subsequent data collection will be by means of a Case Report Form, which will be completed in paper form, or electronically. The majority of data points will be added through linkage to routinely collected Trauma Audit and Research Network (TARN) data. A small amount of other information will be added by research nurses, following review of patients’ records. Post-discharge mortality and healthcare resource use data will be obtained from hospital records and supplemented by data from the Office for National Statistics (ONS). Routine sources will be supplemented with data obtained from site-specific questionnaires for intervention costing, and a single questionnaire administered at 6 months follow-up will collect information on primary and community care resource use, use of rehabilitative services, functional outcomes (extended Glasgow Outcome Scale, GOS-E) and Quality of life assessed using the EQ-5D-5L. Study size: We expect to randomise approximately 120 patients from at least 10 large MTCs across England. The total study size is determined by the relative infrequency of trauma patients with life-threatening torso haemorrhage. Milestones (in months): 0-6: Study start up, recruitment and training of staff 0-6: Training of pilot centres 7-15: Feasibility assessment 15: Stop/go assessment (to full trial) 16-39: Recruitment and randomisation to full trial 39: Completion of primary outcome (mortality at 90 days) 39-45: Completion of 6 month follow-up 45-48: Final analyses 48: Final report Recruitment rate: 0.5 patients per month per site

Lay abstract: 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.

Research activity codes: 6.3 MEDICAL DEVICES;6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS