Low-Molecular-Weight Heparin (LMWH) for Deep Venous Thrombosis (DVT) Prophylaxis
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ClinicalTrials.gov Identifier: NCT01029821 |
Recruitment Status
: Unknown
Verified June 2011 by University of Tennessee.
Recruitment status was: Recruiting
First Posted
: December 10, 2009
Last Update Posted
: June 16, 2011
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Deep Venous Thrombosis | Drug: Low-Molecular-Weight Heparin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | February 2010 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Low-Molecular-Weight Heparin for DVT
Low-Molecular-Weight Heparin for DVT Prophylaxis after Open Reduction and Internal Fixation of ankle fractures
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Drug: Low-Molecular-Weight Heparin
Isolated Ankle Fracture Single planned operation
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- 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) ]
- 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) ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029821
Contact: Stan Ragon, M.D. | 423-778-9202 | stanragon@hotmail.com | |
Contact: Elaine Pugh | 423-778-5663 | elaine.pugh@erlanger.org |
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. |
Principal Investigator: | Dale Ingram, M.D. | University of Tennessee |
Responsible Party: | Elaine Pugh, UTennessee |
ClinicalTrials.gov Identifier: | NCT01029821 History of Changes |
Other Study ID Numbers: |
Pugh-2 |
First Posted: | December 10, 2009 Key Record Dates |
Last Update Posted: | June 16, 2011 |
Last Verified: | June 2011 |
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 |