Life-threatening torso haemorrhage Injury, Occupational Diseases, Poisoning
Conditions
Interventions
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
Sponsors
University of Aberdeen and NHS Grampian
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed