The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

NCT ID: NCT00170378

Last Updated: 2017-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2005-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Brain Injury Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Enoxaparin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aventis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Hennepin Healthcare Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John K. Cumming, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hennepin County Medical Center/MinneapolisMRF

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12131387 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12049541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11220715 (View on PubMed)

Other Identifiers

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HSR #02-2113

Identifier Type: -

Identifier Source: org_study_id

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