Low-Molecular-Weight Heparin (LMWH) for Deep Venous Thrombosis (DVT) Prophylaxis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of Tennessee.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Tennessee
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT01029821
First received: December 9, 2009
Last updated: June 15, 2011
Last verified: June 2011
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Purpose
- 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.
| Condition | Intervention |
|---|---|
|
Deep Venous Thrombosis |
Drug: Low-Molecular-Weight Heparin |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Low-Molecular-Weight Heparin for DVT Prophylaxis After Open Reduction and Internal Fixation of Ankle Fractures: A Randomized, Prospective Trial |
Resource links provided by NLM:
MedlinePlus related topics:
Ankle Injuries and Disorders
Blood Clots
Blood Thinners
Body Weight
Deep Vein Thrombosis
Fractures
U.S. FDA Resources
Further study details as provided by University of Tennessee:
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. [ Time Frame: first post-operative office visit (usually 10-14 days) ] [ Designated as safety issue: No ]
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. [ Time Frame: first post-operative office visit (10-14 days) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Low-Molecular-Weight Heparin for DVT
Low-Molecular-Weight Heparin for DVT Prophylaxis after Open Reduction and Internal Fixation of ankle fractures
|
Drug: Low-Molecular-Weight Heparin
Isolated Ankle Fracture Single planned operation
|
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029821
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029821
Contacts
| Contact: Stan Ragon, M.D. | 423-778-9202 | stanragon@hotmail.com | |
| Contact: Elaine Pugh | 423-778-5663 | elaine.pugh@erlanger.org |
Locations
| United States, Tennessee | |
| Erlanger Medical Center | Recruiting |
| Chattanooga,, Tennessee, United States, 37403 | |
| Contact: Dale Ingram, M.D. 423-266-3719 | |
| Contact: Stan Ragon, M.D 423-778-9292 stanragon@hotmail.com | |
| Principal Investigator: Dale Ingram, M.D. | |
Sponsors and Collaborators
University of Tennessee
Investigators
| Principal Investigator: | Dale Ingram, M.D. | University of Tennessee |
More Information
| Responsible Party: | Elaine Pugh, UTennessee |
| ClinicalTrials.gov Identifier: | NCT01029821 History of Changes |
| Other Study ID Numbers: | Pugh-2 |
| Study First Received: | December 9, 2009 |
| Last Updated: | June 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Tennessee:
|
Low-Molecular-Weight-Heparin Open Reduction and Internal Fixation Thromboprophylaxis |
Additional relevant MeSH terms:
|
Thrombosis Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Calcium heparin Heparin |
Heparin, Low-Molecular-Weight Dalteparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 26, 2016