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

Deep Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01029821
• Other study ID #: Pugh-2
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2009
• Last updated: June 15, 2011
• Start date: February 2010
• Est. completion date: December 2013

Study information

• Verified date: June 2011
• Source: University of Tennessee
• Contact: Stan Ragon, M.D.
• Phone: 423-778-9202
• Email: stanragon[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Low-Molecular-Weight Heparin
Isolated Ankle Fracture Single planned operation

Locations

Country	Name	City	State
United States	Erlanger Medical Center	Chattanooga,	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No