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The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT00170378
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation

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 Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
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 : December 2002
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Heparin
U.S. FDA Resources




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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00170378     History of Changes
Other Study ID Numbers: HSR #02-2113
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: October 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Minneapolis Medical Research Foundation:
Enoxaparin
Safety

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