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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by University of Tennessee.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01029821
First Posted: December 10, 2009
Last Update Posted: June 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Tennessee
  Purpose
  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.

Condition Intervention
Deep Venous Thrombosis Drug: Low-Molecular-Weight Heparin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-Molecular-Weight Heparin for DVT Prophylaxis After Open Reduction and Internal Fixation of Ankle Fractures: A Randomized, Prospective Trial

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 100
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029821


Contacts
Contact: Stan Ragon, M.D. 423-778-9202 stanragon@hotmail.com
Contact: Elaine Pugh 423-778-5663 elaine.pugh@erlanger.org

Locations
United States, Tennessee
Erlanger Medical Center Recruiting
Chattanooga,, Tennessee, United States, 37403
Contact: Dale Ingram, M.D.    423-266-3719      
Contact: Stan Ragon, M.D    423-778-9292    stanragon@hotmail.com   
Principal Investigator: Dale Ingram, M.D.         
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Dale Ingram, M.D. University of Tennessee
  More Information

Responsible Party: Elaine Pugh, UTennessee
ClinicalTrials.gov Identifier: NCT01029821     History of Changes
Other Study ID Numbers: Pugh-2
First Submitted: December 9, 2009
First Posted: December 10, 2009
Last Update Posted: June 16, 2011
Last Verified: June 2011

Keywords provided by University of Tennessee:
Low-Molecular-Weight-Heparin
Open Reduction and Internal Fixation
Thromboprophylaxis

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action