The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00170378

Enrollment

300

Registered

2005-09-15

Start date

2002-12-31

Completion date

2005-08-31

Last updated

2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury, Venous Thrombosis

Keywords

Enoxaparin, Safety

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.

Interventions

DRUGEnoxaparin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety: Assess if early administration of LMWH exacerbates intracranial hemorrhage.	—

Secondary

Measure	Time frame
Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026