NCT03081169

Timing of VTE Prophylaxis in TBI

Timing of Venous Thromboembolism Prophylaxis in Traumatic Brain Injury

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients in both treatment groups will be monitored for development of VTE as well as complications from bleeding after commencement of VTE prophylaxis.

Detailed description

This a randomized prospective study that compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients who are identified as having an intracranial injury will be randomized to early versus late VTE prophylaxis using a 1:1 random numbers allocation. Patients in both treatment groups will be monitored for development of VTE, primarily with scheduled duplex ultrasound studies of the lower extremities. Any clinical suspicion of VTE will also be investigated with duplex ultrasound and/or CT angiogram of the chest. Patients will be monitored for development of complications from bleeding post commencement of VTE prophylaxis. Intracranial bleeding complications will be monitored by physical examination and CT scanning of the head when indicated. Patients who undergo craniotomy or craniectomy will have VTE prophylaxis started 72 hours post-surgery and will undergo CT scan of the head (to assure bleeding stabilization) prior to administration of VTE prophylaxis.

Conditions

• TBI (Traumatic Brain Injury)
• VTE (Venous Thromboembolism)

Interventions

Type	Name	Description
DRUG	Enoxaparin Sodium 150 MG/ML Prefilled Syringe	The same drugs and dosages will be used in both groups, with only the timing being different
DRUG	Heparin	The same drugs and dosages will be used in both groups, with only the timing being different

Timeline

• Start date: 2017-04-03
• Primary completion: 2019-08-12
• Completion: 2019-08-12
• First posted: 2017-03-16
• Last updated: 2019-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study