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
Recruitment status was Not yet recruiting
Sponsor:
University of California, Davis
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013