This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paul Di Cesare,MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00909064
First received: May 22, 2009
Last updated: April 5, 2017
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: Intervention Model: Single Group Assignment
Masking: No masking
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 Paul Di Cesare,MD, University of California, Davis:

Primary Outcome Measures:
  • Number of Days Until a Dry Wound [ Time Frame: Up to 10 days ]
    Days from day of surgery to stoppage of leakage from the wound


Secondary Outcome Measures:
  • Number of Days in Hospital. [ Time Frame: Up to 10 days ]
    Days after surgery to dischage

  • Incidence of Wound Infection [ Time Frame: Up to 10 days ]
    Incidence of Cellulitis in patients undergoing Arixtra treatment


Enrollment: 114
Study Start Date: June 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arixtra
Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement
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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, California
U C Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
Paul Di Cesare,MD
Investigators
Principal Investigator: Paul E. DiCesare, MD University of California, Davis Health System
  More Information

Responsible Party: Paul Di Cesare,MD, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00909064     History of Changes
Other Study ID Numbers: 200816251
GSK576428
Study First Received: May 22, 2009
Results First Received: April 5, 2017
Last Updated: April 5, 2017

Additional relevant MeSH terms:
Fondaparinux
PENTA
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 28, 2017