Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
1500

Summary

Conditions
Traumatic Brain Injury
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Prevention

Participation Requirements

Age
Between 16 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT03559114
Collaborators
  • Sunnybrook Research Institute
  • Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Farhad Pirouzmand, MD, MSc, FRCSC Sunnybrook Health Sciences Centre Principal Investigator: Damon Scales, MD, PhD, FRCPC Sunnybrook Health Sciences Centre
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