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