Medical condition: Traumatic Brain Injury (TBI) Medical condition in lay language: Severe brain injury following an accident Therapeutic areas: Diseases [C] - Injuries, poisonings, and occupational diseases [C21] Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Early pharmacologic thromboprophylaxis (PTP) arm - defined as administration of PTP within 72 hours of TBI
Late PTP arm - defined as administration of PTP after a minimum of 120 hours from TBI or PTP
Sponsors
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients (=16 years of age) 2. Acute TBI (defined as acute traumatic changes on CT brain, either in isolation or in the context of polytrauma) 3. Patients admitted to hospital within 72 hours of injury
Exclusion criteria
Exclusion criteria: 1. Patients with recent Venous Thromboembolism (VTE) - within 3 months before TBI 2. Known hypersensitivity to any VTE prophylaxis agents to be used in this trial 3. Patients not expected to live beyond 72 hours 4. Time interval from injury to randomisation exceeding 72 hours 5. Participation in the same study within last 12 months 6. Current use of anticoagulation for an alternative indication, with a clinical decision to continue 7. Acute bleeding deemed serious enough that the treating clinical team lack equipoise for the study question 8. Progression of early traumatic intracranial haemorrhage or unstable neurological condition, such that the treating clinical team lack equipoise for the study questions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptomatic DVT or PE will be investigated as per standard clinical practice either by compression Doppler ultrasound of the femoral and popliteal veins or CTPA, as appropriate, within 30 days from randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Any asymptomatic proximal DVT as part of symptomatic screening ultrasound diagnosed from the day of randomisation up until day 29 post-randomisation 2. Progression of intracranial haemorrhage requiring neurosurgical intervention measured using CT brain scans within 14 days after randomisation 3. Progression of intracranial haemorrhage on routinely performed imaging. All CT brain scans will be used for measurement from admission to discharge. 4. Adverse events, of special interest (AESI) including major and clinically relevant bleeding events (assessed and reported in accordance with criteria published by the International Society of Thrombosis and Haemostasis) will be measured throughout the trial 5. VTE will be investigated as per standard clinical practice either by compression Doppler ultrasound of the femoral and popliteal veins or CTPA, as appropriate, at 90 days 6. Mortality measured using data collected in medical notes on day 7, day 30 and month 12 7. Patient functional outcome measured using the Glasgow Outcome Scale-Extended (GOSE) questionnaire and using data collected during telephone interviews at 6 and 12 months 8. Quality of life measured using the EQ-5D-5L questionnaire at day 30 or discharge, 6 and 12 months 9. Length of stay of index admission measured using data collected in medical notes at one time point 10. Economic analysis measured using data collected in medical notes at several time points | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed