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The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

This study has suspended participant recruitment.
Aventis Pharmaceuticals
Information provided by:
Minneapolis Medical Research Foundation Identifier:
First received: September 12, 2005
Last updated: October 3, 2012
Last verified: October 2012
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
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:

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00170378

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

Publications: Identifier: NCT00170378     History of Changes
Other Study ID Numbers: HSR #02-2113
Study First Received: September 12, 2005
Last Updated: October 3, 2012

Keywords provided by Minneapolis Medical Research Foundation:

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Venous Thrombosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on June 23, 2017