The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

Phase 4

Completed

• Conditions: Brain Injury; Venous Thrombosis

• Registration Number: NCT00170378
• Lead Sponsor: Hennepin Healthcare Research Institute

Brief Summary

To study the safety and efficacy of early administration of Low Molecular Weight Heparin to patients with traumatic brain injury.

Detailed Description

Venous thromboembolic (VTE) prophylaxis in trauma patients is a critical clinical problem. Patients with traumatic brain injury usually have effective VTE prophylaxis withheld secondary to concerns of exacerbating intracranial hemorrhage. This study examines the safety and efficacy of early administration (within 24 hrs of admission) of low molecular weight heparin to this patient population with very high VTE risk.

Study Timeline

• Study Start: 2002-12
• Study Completion: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2012-10
• Last Update Submitted: 2017-06-26
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Blunt traumatic brain injury (Marshall II-V)
• Stable 6 hr. head CT
• Stable hemoglobin

Exclusion Criteria

• Premorbid coagulopathy
• Pregnancy
• < 18 y.o.
• Need for therapeutic anticoagulation
• Heparin allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety: Assess if early administration of LMWH exacerbates intracranial hemorrhage.

Secondary Outcome Measures

Name	Time	Method
Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE.

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States