Timing of VTE Prophylaxis in TBI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2019-08-12

Brief Summary

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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.

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Detailed Description

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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

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TBI (Traumatic Brain Injury) VTE (Venous Thromboembolism)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Early (24 hours)

Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 24 hours after injury if CT head is stable.

Group Type ACTIVE_COMPARATOR