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
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

December 9, 2009
June 15, 2011
February 2010
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01029821 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Low-Molecular-Weight Heparin (LMWH) for Deep Venous Thrombosis (DVT) Prophylaxis
Low-Molecular-Weight Heparin for DVT Prophylaxis After Open Reduction and Internal Fixation of Ankle Fractures: A Randomized, Prospective Trial
  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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Deep Venous Thrombosis
Drug: Low-Molecular-Weight Heparin
Isolated Ankle Fracture Single planned operation
Low-Molecular-Weight Heparin for DVT
Low-Molecular-Weight Heparin for DVT Prophylaxis after Open Reduction and Internal Fixation of ankle fractures
Intervention: Drug: Low-Molecular-Weight Heparin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
Yes
Contact: Stan Ragon, M.D. 423-778-9202 stanragon@hotmail.com
Contact: Elaine Pugh 423-778-5663 elaine.pugh@erlanger.org
United States
 
NCT01029821
Pugh-2
Yes
Elaine Pugh, UTennessee
University of Tennessee
Not Provided
Principal Investigator: Dale Ingram, M.D. University of Tennessee
University of Tennessee
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP