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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Deep Venous Thrombosis	Drug: Low-Molecular-Weight Heparin	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
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
Study Start Date :	February 2010
Estimated Primary Completion Date :	December 2013
Estimated Study Completion Date :	December 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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) ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Elaine Pugh, UTennessee
ClinicalTrials.gov Identifier:	NCT01029821 History of Changes
Other Study ID Numbers:	Pugh-2
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