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

June 15, 2011 updated by: University of Tennessee

Low-Molecular-Weight Heparin for DVT Prophylaxis After Open Reduction and Internal Fixation of Ankle Fractures: A Randomized, Prospective Trial

  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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Chattanooga,, Tennessee, United States, 37403
        • Recruiting
        • Erlanger Medical Center
        • Contact:
          • Dale Ingram, M.D.
          • Phone Number: 423-266-3719
        • Contact:
        • Principal Investigator:
          • Dale Ingram, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low-Molecular-Weight Heparin for DVT
Low-Molecular-Weight Heparin for DVT Prophylaxis after Open Reduction and Internal Fixation of ankle fractures
Drug: Low-Molecular-Weight Heparin
Isolated Ankle Fracture Single planned operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
We will compare the rates of thrombi formation between the two groups. We will record any clinical significant thrombi or complications that arise from thrombi. We will record any complications related to administration of LMWH.
Time Frame: first post-operative office visit (usually 10-14 days)
first post-operative office visit (usually 10-14 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
We may find that there is in fact significant benefit to giving prophylaxis to this subset of patients in the form of decreased rates of throb\mbus formation and the complications related to thrombi. The risk/benefit ratio should be favorable.
Time Frame: first post-operative office visit (10-14 days)
first post-operative office visit (10-14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Investigators

  • Principal Investigator: Dale Ingram, M.D., University Of Tennessee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 9, 2009

First Posted (Estimate)

December 10, 2009

Study Record Updates

Last Update Posted (Estimate)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 15, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pugh-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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