The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of California, Davis.
Recruitment status was  Not yet recruiting
Information provided by:
University of California, Davis Identifier:
First received: May 22, 2009
Last updated: May 26, 2009
Last verified: May 2009

The investigators hypothesize that Arixtra patients will be less likely to experience wound infection than patients who have received low-molecular weight heparin, coumadin or aspirin with mechanical compression.

Condition Intervention Phase
Total Knee Replacement
Drug: Fondaparinux Sodium (Arixtra)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty

Resource links provided by NLM:

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Number of days until a dry wound [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1.Number of days in hospital. 2.Incidence of wound infection. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 91
Study Start Date: June 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fondaparinux Sodium (Arixtra)
    2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
    Other Name: Arixtra

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All primary unilateral TKA and THA cases will be included.

Exclusion Criteria:

  • Patients less than 50 kg, Patients with CrCl<30ml/min. Revision and bilateral procedures will be excluded.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00909064

Contact: Anto Fritz, M D 925 785 0826

United States, California
U C Davis Not yet recruiting
Sacramento, California, United States, 95817
Contact: Anto Fritz, MD    925-785-0826   
Sponsors and Collaborators
University of California, Davis
Principal Investigator: Paul E. DiCesare, MD University of California, Davis Health System
  More Information

No publications provided

Responsible Party: Dr. Paul E. Di Cesare, University of California Davis Health System Identifier: NCT00909064     History of Changes
Other Study ID Numbers: 200816251-2, GSK576428
Study First Received: May 22, 2009
Last Updated: May 26, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on October 07, 2015