The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

Hennepin Healthcare Research Institute300 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

300

Conditions

Brain Injury Venous Thrombosis

Interventions

EnoxaparinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE.

Data from ClinicalTrials.gov

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