The Use of Low Molecular Weight Heparin in Traumatic Brain Injury
June 26, 2017 updated by: Hennepin Healthcare Research Institute
To study the safety and efficacy of early administration of Low Molecular Weight Heparin to patients with traumatic brain injury.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment
300
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety: Assess if early administration of LMWH exacerbates intracranial hemorrhage.
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Secondary Outcome Measures
Outcome Measure |
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Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: John K. Cumming, M.D., Hennepin County Medical Center/MinneapolisMRF
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1097/00005373-200207000-00008.
- 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. doi: 10.1001/archsurg.137.6.696.
- 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. doi: 10.1016/s1072-7515(00)00802-4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2002
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Actual)
June 27, 2017
Last Update Submitted That Met QC Criteria
June 26, 2017
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Embolism and Thrombosis
- Craniocerebral Trauma
- Trauma, Nervous System
- Brain Injuries
- Wounds and Injuries
- Brain Injuries, Traumatic
- Thrombosis
- Venous Thrombosis
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Enoxaparin
Other Study ID Numbers
- HSR #02-2113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.