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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 11 September 2017
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: Ongoing
URL:  http://isrctn.com/ISRCTN16184981
Study type:  Interventional
Study design:  Randomised; Interventional; Design type: Treatment, Device (Treatment)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name:  
Address: 
Telephone:
Email:
Affiliation: 
Name: Claire  Cochran
Address:  Centre for Healthcare Randomised Trials (CHaRT) Health Services Research Unit University of Aberdeen Health Sciences Building Foresterhill AB25 2ZD Aberdeen United Kingdom
Telephone: +44 (0)1224 438171
Email: claire.cochran@abdn.ac.uk
Affiliation: 
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
Specialty: Injuries and emergencies, Primary sub-specialty: Injuries and emergencies; UKCRC code/ Disease: Injuries and Accidents/ Certain early complications of trauma
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)
35059
Source(s) of Monetary Support
NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 14/199/09
Secondary Sponsor(s)
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