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

Study Overview
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Brief Summary
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The use of LMWH following open reduction and internal fixation of ankle fractures will reduce the number of thrombi formed. The rates of clinically significant DVT will be equivalent between two groups.

Detailed Description
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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.

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

Conditions
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Deep Venous Thrombosis

Intervention / Treatment
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* Drug: Low-Molecular-Weight Heparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | first post-operative office visit (usually 10-14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | first post-operative office visit (10-14 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low-Molecular-Weight-Heparin, Open Reduction and Internal Fixation, Thromboprophylaxis