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
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00909064
First received: May 22, 2009
Last updated: May 26, 2009
Last verified: May 2009
  Purpose

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
  Eligibility

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

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
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: NCT00909064

Contacts
Contact: Anto Fritz, M D 925 785 0826 atfritz@ucdavis.edu

Locations
United States, California
U C Davis Not yet recruiting
Sacramento, California, United States, 95817
Contact: Anto Fritz, MD    925-785-0826    atfritz@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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
ClinicalTrials.gov 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:
Fondaparinux
PENTA
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014