Submission date
14/08/2017
Registration date
23/08/2017
Last edited
16/10/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
✓ Prospectively registered
✓ Protocol added
? SAP not yet added
✓ Results added
? Raw data not yet added
✓ Study completed

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?
University of Aberdeen (UK)

When is the study starting and how long is it expected to run for?
April 2017 to March 2023

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

Who is the main contact?
Ms Gillian Ferry, gillian.ferry@abdn.ac.uk

Study website

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

Contact information

Type

Scientific

Contact name

Ms Gillian Ferry

ORCID ID

http://orcid.org/0009-0006-9012-9271

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 438124
gillian.ferry@abdn.ac.uk

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

CPMS 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(s)

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

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

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

Condition

Life-threatening torso haemorrhage

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

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 study start date

01/04/2017

Overall study end date

31/03/2023

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Sex

Both

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Total final enrolment

90

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

30/03/2022

Locations

Countries of recruitment

England, United Kingdom

Study participating centre

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

Study participating centre

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

Study participating centre

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

Study participating centre

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

Study participating centre

Queen Elizabeth Hospital Birmingham
University Hospitals Birmingham NHS Foundation Trust
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom

Study participating centre

Southmead Hospital
North Bristol NHS Trust
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom

Study participating centre

University Hospitals Coventry and Warwickshire
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Study participating centre

The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Study participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Study participating centre

John Radcliffe Hospital
Oxford University Hospitals NHS Foundation Trust
Headley Way
Oxford
OX3 9DU
United Kingdom

Study participating centre

Royal Hallamshire Hospital
Sheffield Teaching Hospitals NHS Foundation Trust
Glossop Road
Sheffield
S10 2JF
United Kingdom

Study participating centre

St George's University Hospitals NHS Foundation Trust
Blackshaw Road
London
SW17 0QT
United Kingdom

Study participating centre

Royal Stoke University Hospital
University Hospitals of North Midlands NHS Trust
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

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
Scotland
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.

Intention to publish date

31/08/2023

Individual participant data (IPD) sharing plan

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

IPD sharing plan summary

Not expected to be made available

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version V2 20/07/2017 02/04/2019 No No
Interim results article 12/05/2022 16/05/2022 Yes No
Protocol article 12/05/2022 16/05/2022 Yes No
HRA research summary 28/06/2023 No No
Results article 12/10/2023 16/10/2023 Yes No

Additional files

Editorial Notes

16/10/2023: Publication reference added. 09/05/2023: The following changes were made to the trial record: 1. The contact was changed. 2. The intention to publish date was changed from 30/04/2023 to 31/08/2023. 3. The plain English summary was updated to reflect these changes. 16/05/2022: Publication references added. 12/05/2022: The following changes have been made: 1. The recruitment end date has been changed from 30/06/2022 to 30/03/2022. 2. The overall trial end date has been changed from 31/12/2022 to 31/03/2023 and the plain English summary updated accordingly. 3. The final enrolment number has been added. 02/03/2021: The following changes have been made: 1. The recruitment end date has been changed from 30/06/2020 to 30/06/2022. 2. The overall trial end date has been changed from 30/03/2021 to 31/12/2022. 3. The intention to publish date has been changed from 30/03/2021 to 30/04/2023. 4. The plain English summary has been updated to reflect the changes above. 03/09/2020: Recruitment for this study is no longer paused as of 13/07/2020. 05/05/2020: The following changes were made to the trial record: 1. The trial participating centres "Queen Elizabeth Hospital Birmingham, Southmead Hospital, University Hospitals Coventry & Warwickshire, James Cook University Hospital, Royal Victoria Infirmary, John Radcliffe Hospital, Royal Hallamshire Hospital, St George's University Hospitals NHS Foundation Trust, Royal Stoke University Hospital" were added. 2. The plain English summary was updated to reflect these changes. 05/05/2020: Due to current public health guidance, recruitment for this study has been paused. 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).