Each year around 5400 people in England and Wales die after being severely injured – for example, in a road traffic collision, or as a result of a major fall. The leading cause of preventable death following injury is uncontrolled bleeding, which usually requires immediate surgery. However, some patients die before they can reach an operating theatre.
REBOA (which stands for Resuscitative Endovascular Balloon Occlusion of the Aorta) is a new technique which could help with this. REBOA involves passing a small inflatable balloon into the aorta (the main artery) to stop the bleeding until a patient can be taken to an operating theatre.
Aim
To establish the clinical and cost-effectiveness of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA), in addition to standard major trauma centre treatment, for the treatment of patients with life-threatening torso haemorrhage.
Design
Bayesian group-sequential randomised controlled trial, comparing standard major trauma centre treatment plus REBOA with standard major trauma centre treatment alone.
Setting
Major trauma centres in England.
Participants
Adult trauma patients (aged, or believed to be aged, 16 years or older) presenting to major trauma centres with suspected life-threatening torso haemorrhage. Exclusion criteria: Women known or thought to be pregnant; injuries deemed clinically unsurvivable.
Primary outcome
Primary outcome: 90-day mortality.
Device
The trial allows the use of any REBOA device. Trial centres may use their device of choice; however, the trial will be able to provide the ER-REBOATM balloon, a second-generation, low-profile (7F), guidewire-free system.
Study size
We expect to randomise approximately 120 patients.
Study phases
Feasibility assessment phase: Conducted in five major trauma centres, over 9 months.
Full trial: Conducted in at least ten major trauma centres, over 24 months.
Implementation and training
Participating major trauma centres will receive two days’ of on-site training and implementation assistance, which will include individual skills and team training, advice on integration with existing processes (such as trauma calls, code reds, major haemorrhage protocols), training of “downstream” staff (such as anaesthetists and surgeons), and trial procedures.
Randomisation and consent
Patients will be enrolled and randomised by trauma team leaders, using a novel smartphone website. This will ensure that patients can be entered into the trial within seconds, and without interfering with clinical care. Eligible patients will not be able to provide informed consent, and the trial will therefore be conducted under the auspices of the Mental Capacity Act (2005).
Start date and duration
The trial will commence on 1 April 2017, it will cease in December 2022.
Bleeding is the most common cause of preventable death after severe injury (also known as "trauma").
Treatment for such bleeding is urgent. Research has shown that early treatment saves lives.
Stopping the bleeding usually requires an operation – but some patients die before this can be done.
REBOA (which stands for "Resuscitative Endovascular Balloon Occlusion of the Aorta") is a new treatment for trauma patients with severe bleeding.
REBOA involves passing a small inflatable balloon into the aorta (your main artery), to stop the bleeding, until you can be taken to an operating theatre. The balloon is then removed.
Clinical trials are part of everyday healthcare in the NHS and help us to work out which treatments work and which do not.
It is essential that we find out if REBOA is helpful. The National Institute for Health Research is funding our clinical trial to answer this question.
This means that if you suffer injuries resulting in serious bleeding, you might be randomised to receive REBOA, or current treatment.
Patient and Public Consultation has helped and advised us on many aspects of the trial design.
Bleeding is the most common cause of preventable death after severe injury (also known as "trauma"). Treatment for such bleeding is urgent. Research has shown that early treatment saves lives. Stopping the bleeding usually requires an operation – but some patients die before this can be done.
REBOA (which stands for "Resuscitative Endovascular Balloon Occlusion of the Aorta") is a new treatment for trauma patients with severe bleeding. REBOA involves passing a small inflatable balloon into the aorta (your main artery), to stop the bleeding, until you can be taken to an operating theatre. The balloon is then removed.
Clinical trials are part of everyday healthcare in the NHS and help us to work out which treatments work and which do not. It is essential that we find out if REBOA is helpful. The National Institute for Health Research is funding our clinical trial to answer this question. This means that if you suffer injuries resulting in serious bleeding, you might be randomised to receive REBOA, or current treatment.
The UK-REBOA Trial is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project number 14/199/09). Please visit each organisation's website for more information.
University of Aberdeen is the sponsor for this study based in the United Kingdom. The University of Aberdeen will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. University of Aberdeen/NHS Grampian will keep identifiable information about you at least 10 years after the study has finished.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
As a publicly-funded organisation, and to comply with article 6 (1)(e) and 9(2)(j) of the GDPR, we have to ensure that it is in the public interest when we use personally-identifiable information in our research.
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