PROTEST Trial - PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury, a Double-blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 1,100
- Locations
- 12
- Primary Endpoint
- Clinically important VTE
Study Overview
Brief Summary
This is a pilot study, phase III, multi-centre, double blind, randomized controlled trial of patients with traumatic brain injury (TBI).
Detailed Description
Patients with severe brain injury are at risk for developing blood clots in their legs, which can travel to the lungs. This potentially serious complication is known as venous thromboembolism (VTE). Anticoagulants are commonly used to prevent VTE in hospital patients. However, in patients with major head injury, anticoagulant prevention is commonly delayed for the fear that it can potentially lead to further bleeding in the brain. Another method that aims to prevent blood clots involves the use of sequential compression device (SCD) that compress the legs and increase the flow of blood in the leg veins.
This study will compare results from patients who receive the SCDs only to those who receive both SCD and anticoagulants. The outcome of this study will provide information about how best to prevent blood clots while not increase brain bleeding after head injury.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Anticoagulant
Dalteparin sodium (at a dose of 5000 IU once daily by subcutaneous injection) for 7 days upon randomization after hospital admission.
Intervention: Dalteparin (Drug)
Saline
Saline (0.2 mL) once daily by subcutaneous injection for 7 days upon randomization after hospital admission.
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
Clinically important VTE
Time Frame: 8 days
Composite outcome of clinically-important VTE within 7±1 days after randomization defined as any of: 1. Symptomatic, objectively-confirmed pulmonary embolism (PE), or 2. Symptomatic, objectively-confirmed, proximal leg deep vein thrombosis (DVT), or 3. Proximal (above knee) leg DVT on compression ultrasonography on Day 7±1
Secondary Outcomes
- 180-day Mortality(180 days)
- Functional neurological outcome at day 30 as measured by Glasgow Outcome Scale Extended(30 days)
- Clinically-important ICB (Intracranial bleeding) progression(7 days)
- Objectively confirmed new or progressing ICB on radiology,(8 days)
- Functional neurological outcome at day 180 as measured by Glasgow Outcome Scale Extended(180 days)
- Quality of life outcome at 180 days as measured by the EuroQol5D(180 days)
- 7-day Mortality(7 days)
- Quality of life outcome at 30 days as measured by the EuroQol5D(30 days)
- 30-day Mortality(30 days)
- Delayed VTE after day 7(30 days)