The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

• Sponsor: Hennepin Healthcare Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00170378
• Collaborator: Aventis Pharmaceuticals (Industry)
• Enrollment: 300
• Location: 1
• Duration (Months): 32
• Patients Per Site Per Month: 9.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Brain Injury; Venous Thrombosis	Drug: Enoxaparin	Phase 4

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• Official Title: The Use of Low Molecular Weight Heparin in Traumatic Brain Injury
• Study Start Date: Dec 1, 2002
• Actual Study Completion Date: Aug 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415

Sponsors and Collaborators

• Hennepin Healthcare Research Institute
• Aventis Pharmaceuticals

Investigators

• Principal Investigator: John K. Cumming, M.D., Hennepin County Medical Center/MinneapolisMRF

Study Documents (Full-Text)

None provided.

More Information

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, 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.
• 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.

• Responsible Party: Hennepin Healthcare Research Institute
• ClinicalTrials.gov Identifier: NCT00170378
• Other Study ID Numbers: HSR #02-2113
• First Posted: Sep 15, 2005
• Last Update Posted: Jun 27, 2017
• Last Verified: Oct 1, 2012

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Hennepin Healthcare Research Institute: Enoxaparin; Safety
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Thrombosis; Venous Thrombosis; Wounds and Injuries; Enoxaparin

Study Results

No Results Posted as of Jun 27, 2017