Low-Molecular-Weight Heparin (LMWH) for Deep Venous Thrombosis (DVT) Prophylaxis

NCT ID: NCT01029821

Last Updated: 2011-06-16

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-12-31

Brief Summary

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1. The use of LMWH following open reduction and internal fixation of ankle fractures will reduce the number of thrombi formed.
2. The rates of clinically significant DVT will be equivalent between two groups.

Detailed Description

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Routine use of thromboprophylaxis may be over treatment and definitely increases healthcare costs. While prophylaxis may reduce the number of thrombi formed the exact number and clinical significance of these is unknown. This study seeks to answer the question of whether or not DVT prophylaxis with low-molecular-weight heparin (LMWH) following ORIF of ankle fractures is warranted.

Conditions

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Deep Venous Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low-Molecular-Weight Heparin for DVT

Low-Molecular-Weight Heparin for DVT Prophylaxis after Open Reduction and Internal Fixation of ankle fractures

Group Type OTHER

Low-Molecular-Weight Heparin

Intervention Type DRUG

Isolated Ankle Fracture Single planned operation

Interventions

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Low-Molecular-Weight Heparin

Isolated Ankle Fracture Single planned operation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old
* Surgical ankle fracture able to be definitively treated with one operation

Exclusion Criteria

* Younger than 18 years of age
* Other significant injury
* Known hypercoagulable state
* History of bleeding disorder
* History of DVT
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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UTennessee

Principal Investigators

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Dale Ingram, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

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Erlanger Medical Center

Chattanooga, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stan Ragon, M.D.

Role: CONTACT

423-778-9202

Elaine Pugh

Role: CONTACT

423-778-5663

Facility Contacts

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Dale Ingram, M.D.

Role: primary

423-266-3719

Stan Ragon, M.D

Role: backup

423-778-9292

Other Identifiers

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Pugh-2

Identifier Type: -

Identifier Source: org_study_id

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