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

Not Applicable

• Conditions: Deep Venous Thrombosis
• Interventions: Drug: Low-Molecular-Weight Heparin

• Registration Number: NCT01029821
• Lead Sponsor: University of Tennessee

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.

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 Timeline

• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-10
• Study Start: 2010-02
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-15
• Last Update Posted: 2011-06-16
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Molecular-Weight Heparin for DVT	Low-Molecular-Weight Heparin	Low-Molecular-Weight Heparin for DVT Prophylaxis after Open Reduction and Internal Fixation of ankle fractures

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Erlanger Medical Center; 🇺🇸 Chattanooga,, Tennessee, United States