NCT00909064

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
7.5 years until next milestone

Results Posted

Study results publicly available

May 15, 2017

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2009

Enrollment Period

6 months

First QC Date

May 22, 2009

Results QC Date

April 5, 2017

Last Update Submit

April 5, 2017

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

  • Number of Days Until a Dry Wound

    Days from day of surgery to stoppage of leakage from the wound

    Up to 10 days

Secondary Outcomes (2)

  • Number of Days in Hospital.

    Up to 10 days

  • Incidence of Wound Infection

    Up to 10 days

Study Arms (1)

Arixtra

EXPERIMENTAL

Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement

Drug: Fondaparinux Sodium (Arixtra)

Interventions

Fondaparinux Sodium (Arixtra)DRUG

2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.

Also known as: Arixtra
Arixtra

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients less than 50 kg, Patients with CrCl\<30ml/min. Revision and bilateral procedures will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U C Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Fondaparinux

Intervention Hierarchy (Ancestors)

OligosaccharidesPolysaccharidesCarbohydrates

Results Point of Contact

Title
Gavin Pereira
Organization
UC Davis
gcpereira@ucdavis.edu
916-534-0919

Study Officials

  • Paul E. DiCesare, MD

    University of California, Davis Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2009

First Posted

May 27, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 15, 2017

Results First Posted

May 15, 2017

Record last verified: 2009-05

Locations

US(1)