NCT03559114

PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)

PROTEST Trial - PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury, a Double-blind Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Dalteparin	Dalteparin in prophylactic doses administered daily if screening criteria are satisfied.
DRUG	Saline	Saline in prophylactic doses administered daily if screening criteria are satisfied.

Timeline

• Start date: 2018-07-19
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2018-06-15
• Last updated: 2024-09-19

Locations

12 sites across 1 country: Canada