NCT00170378

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

June 27, 2017

Status Verified

October 1, 2012

First QC Date

September 12, 2005

Last Update Submit

June 26, 2017

Conditions

Brain InjuryVenous Thrombosis

Keywords

EnoxaparinSafety

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE.

Interventions

EnoxaparinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Blunt traumatic brain injury (Marshall II-V)
  • Stable 6 hr. head CT
  • Stable hemoglobin

You may not qualify if:

  • Premorbid coagulopathy
  • Pregnancy
  • \< 18 y.o.
  • Need for therapeutic anticoagulation
  • Heparin allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (3)

  • 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.

    PMID: 12131387BACKGROUND

  • 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.

    PMID: 12049541BACKGROUND

  • 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.

    PMID: 11220715BACKGROUND

MeSH Terms

Conditions

Brain InjuriesVenous Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • John K. Cumming, M.D.

    Hennepin County Medical Center/MinneapolisMRF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

December 1, 2002

Study Completion

August 1, 2005

Last Updated

June 27, 2017

Record last verified: 2012-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)