Back to resultsLow-Molecular-Weight Heparin (LMWH) for Deep Venous Thrombosis (DVT) Prophylaxis
Primary Purpose
Deep Venous Thrombosis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Molecular-Weight Heparin
Sponsored by
About this trial
This is an interventional treatment trial for Deep Venous Thrombosis focused on measuring Low-Molecular-Weight-Heparin, Open Reduction and Internal Fixation, Thromboprophylaxis
Eligibility 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
Sites / Locations
- Erlanger Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Low-Molecular-Weight Heparin for DVT
Arm Description
Low-Molecular-Weight Heparin for DVT Prophylaxis after Open Reduction and Internal Fixation of ankle fractures
Outcomes
Primary Outcome Measures
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 Measures
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.
Full Information
NCT ID
NCT01029821
First Posted
December 9, 2009
Last Updated
June 15, 2011
Sponsor
University of Tennessee
1. Study Identification
Unique Protocol Identification Number
NCT01029821
Brief Title
Low-Molecular-Weight Heparin (LMWH) for Deep Venous Thrombosis (DVT) Prophylaxis
Official Title
Low-Molecular-Weight Heparin for DVT Prophylaxis After Open Reduction and Internal Fixation of Ankle Fractures: A Randomized, Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Tennessee
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Venous Thrombosis
Keywords
Low-Molecular-Weight-Heparin, Open Reduction and Internal Fixation, Thromboprophylaxis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low-Molecular-Weight Heparin for DVT
Arm Type
Other
Arm Description
Low-Molecular-Weight Heparin for DVT Prophylaxis after Open Reduction and Internal Fixation of ankle fractures
Intervention Type
Drug
Intervention Name(s)
Low-Molecular-Weight Heparin
Intervention Description
Isolated Ankle Fracture Single planned operation
Primary Outcome Measure Information:
Title
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.
Time Frame
first post-operative office visit (usually 10-14 days)
Secondary Outcome Measure Information:
Title
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.
Time Frame
first post-operative office visit (10-14 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stan Ragon, M.D.
Phone
423-778-9202
Email
stanragon@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine Pugh
Phone
423-778-5663
Email
elaine.pugh@erlanger.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale Ingram, M.D.
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erlanger Medical Center
City
Chattanooga,
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dale Ingram, M.D.
Phone
423-266-3719
First Name & Middle Initial & Last Name & Degree
Stan Ragon, M.D
Phone
423-778-9292
Email
stanragon@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dale Ingram, M.D.
12. IPD Sharing Statement
Learn more about this trial
Low-Molecular-Weight Heparin (LMWH) for Deep Venous Thrombosis (DVT) Prophylaxis
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