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Completed

NCT Number: NCT00170378

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.

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Key information

Conditions

Brain Injury Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Craniocerebral Trauma Embolism and Thrombosis Nervous System Diseases Thrombosis Trauma, Nervous System Vascular Diseases Venous Thrombosis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enoxaparin

Drug

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.

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Collaborators

  • Aventis Pharmaceuticals

Registry information

Important dates

Study start
2002
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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