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

What is the UK-REBOA Trial?

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.


While REBOA has shown early promise we do not yet know whether it is better than the standard care given to trauma patients. This study aims to compare standard major trauma centre care with REBOA versus standard major trauma care alone, in a fair and balanced way. We expect to involve approximately 120 patients in this study, across 10 Major Trauma Centres, over four years.

We will measure a range of outcomes for each patient, and record whether the patient died or survived. This information will be stored centrally, in a national database. We will then compare the outcomes of those who received standard Major Trauma Centre care plus REBOA against those who received standard Major Trauma Care alone. We will also compare the costs of those who received REBOA with those who did not.

We have brought together a national team of experts to undertake this research. The team involves surgeons, emergency medicine doctors, anaesthetists, intensive care doctors, clinical trialists, statisticians and health economists. We also have two patient and public representatives on the team making sure the study is designed well from the patient perspective.
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Scientific Summary

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.

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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, and will last a total of 48 months.

If you would like to contact us, or have any questions?

Centres working with us

The Royal London Hospital

Key people:

Investigator:

  • Mr Samy Sadek

Address:

The Royal London Hospital
Whitechapel Road
London
E1 1BB
St Mary's Hospital, London

Key people:

Investigator:

  • Mr Chris Aylwin

Address:

St Mary's Hospital
Praed Street
London
W2 1NY
Leeds General Infirmary

Key people:

Investigator:

  • Mr Tim Stansfield

Address:

Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
Queen's Medical Centre (QMC)

Key people:

Investigator:

  • Mr Adam Brooks

Address:

Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
Royal Victoria Infirmary, Newcastle

Key people:

Investigator:

  • Mr John Wright

Address:

Royal Victoria Infirmary
Queen Victoria Road
Newcastle
NE 4LP
King's College Hospital, London - coming soon

Key people:

Investigator:

  • Mr Duncan Bew

Address:

King's College Hospital
Denmark Hill
London
SE5 9RS
St George's University Hospital

Key people:

Investigator:

  • Mr Anthony Hudson

Address:

St Georges Hospital,
Morpeth
NE61 2NU
Queen Elizabeth Hospital, Birmingham - coming soon

Key people:

Investigator:

  • Mr Ansar Mahmood

Address:

Queen Elizabeth Hospital
Mindelsohn Way
Edgebaston
Birmingham
B15 2GW
University Hospital

Key people:

Investigator:

  • Mr Arun George

Address:

University Hospital Coventry
Clifford Bridge Road
Walsgrave
CV2 2DX
Aintree Univeristy Hospital - coming soon

Key people:

Investigator:

  • Mr Abdo SATTOUT

Address:

Aintree Univeristy Hospital
Department of Emergency Medicine
Longmoor lane
Liverpool
L9 7AL
Southmead Hospital Bristol

Key people:

Investigator:

  • Mr Julian Thompson

Address:

Southmead Hospital ,
Westbury on Trym
Bristol,
BS10 5 NB

Study news

Recruitment

21/120

Trial sites

Latest addition to sites:

Southmead Hospital Bristol
University Hospital
St George's University Hospital
Royal Victoria Infirmary, Newcastle

Key facts

Key facts

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.

You can find out more information about REBOA here:

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Key questions & answers

Click on questions to find out more

What is the problem?

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.

What is the new treatment which we are studying?

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.

What is the UK-REBOA Trial?

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.

Key contacts

Click on cards to find out more

Organisation

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.

General Data Protection Regulation (GDPR)
Participant Information

University of Aberdeen/NHS Grampian is the sponsor for this study based in the United Kingdom. We 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.

You can find out more about how we use your information https://www.abdn.ac.uk/privacy.