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 other identifier
interventional
100
1 country
1
Brief Summary
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2009
CompletedFirst Posted
Study publicly available on registry
December 10, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJune 16, 2011
June 1, 2011
3.8 years
December 9, 2009
June 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
first post-operative office visit (usually 10-14 days)
Secondary Outcomes (1)
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.
first post-operative office visit (10-14 days)
Study Arms (1)
Low-Molecular-Weight Heparin for DVT
OTHERLow-Molecular-Weight Heparin for DVT Prophylaxis after Open Reduction and Internal Fixation of ankle fractures
Interventions
Isolated Ankle Fracture Single planned operation
Eligibility Criteria
You may qualify if:
- At least 18 years old
- Surgical ankle fracture able to be definitively treated with one operation
You may not qualify if:
- Younger than 18 years of age
- Other significant injury
- Known hypercoagulable state
- History of bleeding disorder
- History of DVT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dale Ingram, M.D.
University of Tennessee
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 9, 2009
First Posted
December 10, 2009
Study Start
February 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
June 16, 2011
Record last verified: 2011-06