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The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00170378
First Posted: September 15, 2005
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
September 12, 2005
September 15, 2005
June 27, 2017
December 2002
Not Provided
Safety: Assess if early administration of LMWH exacerbates intracranial hemorrhage.
Same as current
Complete list of historical versions of study NCT00170378 on ClinicalTrials.gov Archive Site
Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE.
Same as current
Not Provided
Not Provided
 
The Use of Low Molecular Weight Heparin in Traumatic Brain Injury
The Use of Low Molecular Weight Heparin in Traumatic Brain Injury
To study the safety and efficacy of early administration of Low Molecular Weight Heparin to patients with traumatic brain injury.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Brain Injury
  • Venous Thrombosis
Drug: Enoxaparin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
August 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00170378
HSR #02-2113
Not Provided
Not Provided
Plan to Share IPD: No
Minneapolis Medical Research Foundation
Minneapolis Medical Research Foundation
Aventis Pharmaceuticals
Principal Investigator: John K. Cumming, M.D. Hennepin County Medical Center/MinneapolisMRF
Minneapolis Medical Research Foundation
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP