The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

Venous Thrombosis Clinical Trial

Official title:

The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170378
• Other study ID #: HSR #02-2113
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: June 26, 2017
• Start date: December 2002
• Est. completion date: August 2005

Study information

• Verified date: October 2012
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Thrombosis
• Venous Thrombosis
• Wounds and Injuries

Intervention

Drug:
• Enoxaparin

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation	Aventis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Assess if early administration of LMWH exacerbates intracranial hemorrhage.
Secondary	Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE.