The Use of Low Molecular Weight Heparin in Traumatic Brain Injury
Information source: Minneapolis Medical Research Foundation
Information obtained from ClinicalTrials.gov on March 21, 2008
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: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Ending date: August 2005
Last updated: September 12, 2005
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