Timing of VTE Prophylaxis in TBI

TBI (Traumatic Brain Injury) Clinical Trial

Official title: Timing of Venous Thromboembolism Prophylaxis in Traumatic Brain Injury

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03081169
• Study type: Interventional
• Source: Loyola University
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 3, 2017
• Completion date: August 12, 2019