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The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00170378
First received: September 12, 2005
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Brain Injury
Venous Thrombosis
 Drug: Enoxaparin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • Safety: Assess if early administration of LMWH exacerbates intracranial hemorrhage.

Secondary Outcome Measures:
  • Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE.

Estimated Enrollment: 300
Study Start Date: December 2002
Estimated Study Completion Date: August 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170378

Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Aventis Pharmaceuticals
Investigators
Principal Investigator: John K. Cumming, M.D. Hennepin County Medical Center/MinneapolisMRF
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00170378     History of Changes
Other Study ID Numbers: HSR #02-2113
Study First Received: September 12, 2005
Last Updated: October 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Minneapolis Medical Research Foundation:
Enoxaparin
Safety

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Brain Injuries
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
 Wounds and Injuries
Heparin, Low-Molecular-Weight
Dalteparin
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013