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The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

Primary Purpose

Brain Injury, Venous Thrombosis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Enoxaparin

About this trial

This is an interventional prevention trial for Brain Injury focused on measuring Enoxaparin, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hennepin County Medical Center

Outcomes

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.

Full Information

NCT ID

NCT00170378

First Posted

September 12, 2005

Last Updated

June 26, 2017

Sponsor

Hennepin Healthcare Research Institute

Collaborators

Aventis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00170378

Brief Title

The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

Official Title

The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

December 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hennepin Healthcare Research Institute

Collaborators

Aventis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injury, Venous Thrombosis

Keywords

Enoxaparin, Safety

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

300 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Primary Outcome Measure Information:

Title

Safety: Assess if early administration of LMWH exacerbates intracranial hemorrhage.

Secondary Outcome Measure Information:

Title

Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John K. Cumming, M.D.

Organizational Affiliation

Hennepin County Medical Center/MinneapolisMRF

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hennepin County Medical Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55415

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

12131387

Citation

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.

Results Reference

background

PubMed Identifier

12049541

Citation

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.

Results Reference

background

PubMed Identifier

11220715

Citation

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.

Results Reference

background

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The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

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