Condition category
Injury, Occupational Diseases, Poisoning
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims
In the UK around 5800 people die annually after being severely injured. One reason these patients die is because they have suffered from massive internal bleeding. 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 (Resuscitative Endovascular Balloon Occlusion of the Aorta). REBOA 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 doctors time to operate. 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 been widely used because it is new, complicated to learn and it is not certain how safe and effective it is. Only three studies have compared patients who have received REBOA against those who did not, and the 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 to test whether it is better or worse to use REBOA before it is used more widely in the NHS. The aim of this study is to assess the clinical and cost-effectiveness of standard major trauma centre treatment plus REBOA, compared with standard major trauma centre treatment alone, for the management of life-threatening torso haemorrhage (bleeding) in UK major trauma centres.

Who can participate?
Patients aged 16 or older with life-threatening torso haemorrhage

What does the study involve?
Participants are randomly allocated to receive either the standard major trauma centre treatment, or the standard major trauma centre treatment plus REBOA. All participants are followed up for 6 months.

What are the possible benefits and risks of participating?
Participating will help to collect more information about REBOA so that future patients with life-threatening bleeding caused by injury can be treated better. The risks of taking part are small. Most people with life-threatening haemorrhage remember very little about their initial treatment, but there is a possibility that receiving a questionnaire or a visit from a researcher could be upsetting later on.

Where is the study run from?
1. Leeds Major Trauma Centre (UK)
2. St Marys Major Trauma Centre (UK)
3. Nottingham Major Trauma Centre (UK)
4. The Royal London Hospital Emergency Department (UK)

When is the study starting and how long is it expected to run for?
April 2017 to June 2021

Who is funding the study?
NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) (UK)

Who is the main contact?
Ms Claire Cochran

Trial website

Contact information



Primary contact

Ms Claire Cochran


Contact details

Centre for Healthcare Randomised Trials (CHaRT)
Health Services Research Unit
University of Aberdeen
Health Sciences Building
AB25 2ZD
United Kingdom
+44 (0)1224 438171

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised controlled trial of the effectiveness, and cost-effectiveness, of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for trauma


Study hypothesis

The aim of this study is to establish, via a randomised controlled trial, the clinical and cost-effectiveness of standard major trauma centre treatment plus Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA), compared with standard major trauma centre treatment alone, for the management of life-threatening torso haemorrhage in UK major trauma centres.

Ethics approval

North West Greater Manchester South, 26/06/2017, ref: 17/NW/0352

Study design

Randomised; Interventional; Design type: Treatment, Device

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Life-threatening torso haemorrhage


Recruitment is by means of a dedicated and secure website accessible from any brand of handheld device, including smartphones (the preferred option) and tablets (one of which will be provided for each centre). The recruitment of a participant only requires the trauma team leader to enter the patient’s hospital number. This information, together with the site’s and TTL’s details (as previously entered) then links directly to CHaRT’s online randomisation system (which will adopt randomisation by blocks of randomly varying length), which returns the patient’s allocation, to either:
1. Standard major trauma centre treatment
2. Standard major trauma centre treatment plus REBOA

For those randomised to receiving REBOA treatment, the treatment with the REBOA balloon is unlikely to exceed 1 hour. All patients will be followed up for a total of 6 months post randomisation.

Intervention type



Drug names

Primary outcome measure

Primary clinical outcome:
90-day mortality, defined as death within 90 days of injury, before or after discharge from hospital. This outcome is intended to capture any late harmful effects

Primary economic outcome:
Lifetime incremental cost per QALY gained, from a health and personal social services perspective

Secondary outcome measures

Secondary clinical outcomes are all gathered form patient notes/TARN notes and include:
1. In-hospital mortality
2. 6-month mortality
3. Length of stay (in hospital and intensive care unit)
4. 24h blood product use (from injury)
5. Need for haemorrhage control procedure (operation or angioembolisation), defined as whether such a procedure was required (from time of injury)
6. Time from admission to commencement of haemorrhage control procedure (REBOA, operation, or angioembolisation), defined as time to balloon inflation, incision, or first angiogram
7. Complications
8. Functional outcome, measured using the extended Glasgow Outcome Score) at 6 months

Secondary economic outcomes include:
1. 6-month costs from an NHS and from a patient and social services perspective
2. Quality of life, measured using EQ-5D-5L at 6-month follow up
3. Incremental cost per QALY gained at 6 months

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Adult trauma patients (aged, or believed to be aged, 16 or older)
2. Confirmed or suspected life-threatening torso haemorrhage which is thought to be amenable to adjunctive treatment with REBOA (zone I or zone III)

Participant type


Age group




Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Participant exclusion criteria

1. Women known or thought to be pregnant at presentation
2. Children (aged, or believed to be aged 15 or younger)
3. Patients with injuries which are deemed unsurvivable on clinical grounds

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Leeds Major Trauma Centre
Leeds General Infirmary Great George Street
United Kingdom

Trial participating centre

St Marys Major Trauma Centre
Praed Street
W2 1NY
United Kingdom

Trial participating centre

Nottingham Major Trauma Centre
Queens Medical Centre Derby Road
United Kingdom

Trial participating centre

Royal Hospital London Barts Health NHS Trust
The Royal London Hospital Emergency Department Ground Floor Central Tower
E1 1BB
United Kingdom

Sponsor information


University of Aberdeen and NHS Grampian

Sponsor details

c/o Ms Patricia Burns
Research Governance Manager
Foresterhill House Annexe
AB25 2ZB
United Kingdom
+44 (0)1224 554362

Sponsor type

Hospital/treatment centre



Funder type


Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 14/199/09

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in 2021.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to patient confidentiality.

Intention to publish date


Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/04/2019: The condition has been changed from "Specialty: Injuries and emergencies, Primary sub-specialty: Injuries and emergencies; UKCRC code/ Disease: Injuries and Accidents/ Certain early complications of trauma" to " Life-threatening torso haemorrhage" following a request from the NIHR. 02/04/2019: Uploaded protocol (not peer reviewed).