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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2011 by University of Tennessee.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

University of Tennessee

ClinicalTrials.gov Identifier:

NCT01029821

First received: December 9, 2009

Last updated: June 15, 2011

Last verified: June 2011

History of Changes

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 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

Resource links provided by NLM:

MedlinePlus related topics: Ankle Injuries and Disorders Blood Clots Blood Thinners Body Weight Deep Vein Thrombosis Fractures

Drug Information available for: Heparin Heparin sodium

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) ]

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) ]


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)
Sexes Eligible for Study:	All
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

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

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 21, 2017

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