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The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

Information source: Minneapolis Medical Research Foundation
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Injury; Venous Thrombosis

Intervention: Enoxaparin (Drug)

Phase: Phase 4

Status: Suspended

Sponsored by: Minneapolis Medical Research Foundation

Official(s) and/or principal investigator(s):
John K. Cumming, M.D., Principal Investigator, Affiliation: Hennepin County Medical Center/MinneapolisMRF

Summary

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

Clinical Details

Official title: The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

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

Secondary outcome: Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States
Additional Information

Related publications:

Kim J, Gearhart MM, Zurick A, Zuccarello M, James L, Luchette FA. Preliminary report on the safety of heparin for deep venous thrombosis prophylaxis after severe head injury. J Trauma. 2002 Jul;53(1):38-42; discussion 43.

Norwood SH, McAuley CE, Berne JD, Vallina VL, Kerns DB, Grahm TW, Short K, McLarty JW. Prospective evaluation of the safety of enoxaparin prophylaxis for venous thromboembolism in patients with intracranial hemorrhagic injuries. Arch Surg. 2002 Jun;137(6):696-701; discussion 701-2.

Norwood SH, McAuley CE, Berne JD, Vallina VL, Kerns DB, Grahm TW, McLarty JW. A potentially expanded role for enoxaparin in preventing venous thromboembolism in high risk blunt trauma patients. J Am Coll Surg. 2001 Feb;192(2):161-7.

Starting date: December 2002
Last updated: October 3, 2012

Page last updated: August 20, 2015

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