ADVANCE: Armed services trauma rehabilitation outcome study
- Conditions
- Military battlefield traumaInjury, Occupational Diseases, PoisoningLong-term outcomes of physical battlefield trauma casualties, in comparison to a 'non-exposed' group, will examine differential rates of:- cardiovascular risk and disease- osteoarthritis and loss of bone density- mental health outcomes- quality of life outcomes- occupational outcomes
- Registration Number
- ISRCTN57285353
- Lead Sponsor
- Defence Medical Services, MoD
- Brief Summary
2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35717965/ (added 20/06/2022) 2024 Other publications in https://doi.org/10.1016/j.bja.2024.02.019 Pain after combat injury in male UK military personnel deployed to Afghanistan (added 25/03/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Male
- Target Recruitment
- 1145
Exposed Group:
1. UK Armed services personnel
2. Male
3. Sustained physical battlefield trauma, while on deployment in Operation Herrick (Afghanistan), requiring aeromedical evacuation and direct UK hospital admission
4. Injured during 2003 or after
Non-Exposed Group:
1. UK Armed services personnel
2. Male
3. Previously deployed
4. No battlefield trauma, as defined in the inclusion criteria
1. Unwilling or unable to give informed consent
2. Established CVD (previous stroke or transient ischaemic attack [TIA], ischaemic heart disease [IHD], peripheral vascular disease)
3. Past medical history of diabetes
4. Past medical history of renal or liver disease
5. Aged <18 and >50 years
6. Active acute infection with systemic features of sepsis, at the time of first visit, as defined below. Potential participant with active acute infection will be considered for recruitment once the acute illness is treated and resolved
7. Two of three of:
7.1. Temperature >38ºC or <36ºC
7.2. Heart rate >90beats/min
7.3. Respiratory rate >20 breaths/min
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Cardiovascular risk - as determined by pulse wave velocity at 20 years<br>2. Major Adverse Cardiovascular Endpoint (MACE) - Composite Cardiovascular Disease (CVD) endpoint of cardiovascular death, non-fatal myocardial infarction, stroke, transient ischaemic attack (TIA), arterial revascularization (coronary artery bypass grafting, percutaneous coronary intervention, carotid endarterectomy or stenting and peripheral arterial stenting or bypass) at 20 years<br>3. Osteoarthritis of the hip and knee - as determined by patient-reported outcomes and radiographic assessment at 20 years
- Secondary Outcome Measures
Name Time Method At baseline, and after 3, 5, 10, 15 and 20 years:<br>1. Cardiovascular risk as determined by more traditional cardiovascular risk factors (eg. blood pressure and diagnosis of hypertension, lipid profile, blood glucose/diabetes mellitus, smoking history, hsCRP and abdominal waist circumference)<br>2. Cardiovascular disease as determined by individual components of the primary composite CVD score and peripheral vascular disease and other CAD (angina).<br>3. Musculoskeletal disease (osteoarthritis and osteoporosis),<br>4. All-cause mortality<br>5. Pain - back and stump/phantom (if applicable)<br>6. Mental health<br>7. Psychosocial/QoL/occupational/other outcomes<br>8. Functional status