Condition category
Injury, Occupational Diseases, Poisoning
Date applied
14/08/2017
Date assigned
23/08/2017
Last edited
23/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

https://w3.abdn.ac.uk/hsru/REBOA/Public/Public/index.cshtml

Contact information

Type

Scientific

Primary contact

Ms Claire Cochran

ORCID ID

Contact details

Centre for Healthcare Randomised Trials (CHaRT)
Health Services Research Unit
University of Aberdeen
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 438171
claire.cochran@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35059

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Injuries and emergencies, Primary sub-specialty: Injuries and emergencies; UKCRC code/ Disease: Injuries and Accidents/ Certain early complications of trauma

Intervention

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

Other

Phase

Drug names

Primary outcome measures

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

01/04/2017

Overall trial end date

30/03/2021

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

01/10/2017

Recruitment end date

30/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds Major Trauma Centre
Leeds General Infirmary Great George Street
Leeds
LS1 3EX

Trial participating centre

St Marys Major Trauma Centre
Praed Street
London
W2 1NY

Trial participating centre

Nottingham Major Trauma Centre
Queens Medical Centre Derby Road
Nottingham
NG7 2UH

Trial participating centre

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

Sponsor information

Organisation

University of Aberdeen and NHS Grampian

Sponsor details

c/o Ms Patricia Burns
Research Governance Manager
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
+44 (0)1224 554362
researchgovernance@abdn.ac.uk

Sponsor type

Hospital/treatment centre

Website

http://www.abdn.ac.uk/clinicalresearchgovernance/

Funders

Funder type

Government

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

Location

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

30/03/2021

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes