The effectiveness and cost-effectiveness of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for trauma

• Register: ISRCTN
• Last refreshed on: 30 October 2023
• Main ID: ISRCTN16184981
• Date of registration: 23/08/2017
• Prospective Registration: Yes
• Primary sponsor: University of Aberdeen and NHS Grampian
• Public title: The effectiveness and cost-effectiveness of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for trauma
• Scientific title: A randomised controlled trial of the effectiveness, and cost-effectiveness, of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for trauma
• Date of first enrolment: 01/10/2017
• Target sample size: 120
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN16184981
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Treatment, Device (Treatment)
• Phase: Not Applicable

Countries of recruitment

England, United Kingdom

Contacts

• Name: Gillian Ferry

Key inclusion & exclusion criteria

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)
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Life-threatening torso haemorrhage
Injury, Occupational Diseases, Poisoning

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

CPMS 35059

Source(s) of Monetary Support

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

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; North West Greater Manchester South, 26/06/2017, ref: 17/NW/0352

Results

• Results available: Yes
• Date Completed: 31/03/2023