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

Information source: University of Tennessee
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Deep Venous Thrombosis

Intervention: Low-Molecular-Weight Heparin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Tennessee

Official(s) and/or principal investigator(s):
Dale Ingram, M.D., Principal Investigator, Affiliation: University of Tennessee

Overall contact:
Stan Ragon, M.D., Phone: 423-778-9202, Email: stanragon@hotmail.com


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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: 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.

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.


Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.


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

Locations and Contacts

Stan Ragon, M.D., Phone: 423-778-9202, Email: stanragon@hotmail.com

Erlanger Medical Center, Chattanooga,, Tennessee 37403, United States; Recruiting
Dale Ingram, M.D., Phone: 423-266-3719
Stan Ragon, M.D, Phone: 423-778-9292, Email: stanragon@hotmail.com
Dale Ingram, M.D., Principal Investigator
Additional Information

Starting date: February 2010
Last updated: June 15, 2011

Page last updated: August 20, 2015

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