Study Stopped
Change in standard of care, no possibility of recruitment
Evaluation of Wound Drainage After Knee or Hip Arthroplasty
Evaluation of Wound Drainage Following Rivaroxaban (Xarelto) or Warfarin (Coumadin) for Post op Venous Thromboembolism (VTE) Prophylaxis, After Knee or Hip Arthroplasty a Randomized Study.
1 other identifier
interventional
N/A
1 country
1
Brief Summary
To compare side effects and complications relating to use of warfarin or rivaroxaban, tolerance and/or toxicity of these two agents such as drop in hemoglobin post operatively, extent of bruising, quantity of wound drainage, duration of drainage, wound swelling, sub and supra-therapeutic prothrombin times, need for transfusion, and patient tolerance in two randomized groups. Return visits to the operating room, length of stay, and VTE rates will also be compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2014
1 active site
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
January 23, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedDecember 7, 2015
December 1, 2015
1.9 years
January 23, 2014
December 4, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Number of days until a dry wound
Comparative wound oozing time between patients receiving Rivaroxaban and those receiving Warfarin will be measured. Wound will be defined as actively draining if the gauze covering the wound is wet to the edges or if fluid is noted to be originating from the surgical site. The nursing staff will record the wound drainage during the hospital stay and the patient will be instructed in self assessment upon discharge using the patient diary.Wound drainage will be recorded twice daily. Time when the wound appeared dry will be noted.
90 days
Amount and character of wound drainage
Wound assessments, including photographs, will occur by a research team member blinided to the anticoagulant being used at three set points; 2 days, 2 weeks, and 6 weeks postoperatively.
90 days
Secondary Outcomes (3)
Number of days in the hospital postoperatively.
90 days
Incidence of wound infection
90 days
Incidence of additional operations
90 days
Other Outcomes (1)
Survey assessments
90 days
Study Arms (2)
Rivaroxaban (Xarelto)
ACTIVE COMPARATORRivaroxaban dosing will be 10mg once daily beginning on postoperative day 1 for a duration of 30 days.
Warfarin (Coumadin)
ACTIVE COMPARATORWarfarin dosing will be titrated to achieve an INR of 2-3 and dosing will begin on postoperative day 1 for a duration of 30 days.
Interventions
To date there has been little attention to evaluating differences in wound complications following TJA among patients treated with rivaroxaban compared to warfarin.
To date there has been little attention to evaluating differences in wound complications following TJA among patients treated with rivaroxaban compared to warfarin.
Eligibility Criteria
You may qualify if:
- All patients over the age of 18 undergoing primary hip or knee replacement by Dr. Urquhart or Dr. Hallstrom.
You may not qualify if:
- Patients with a contraindication to pharmacologic VTE prophylaxis such as hemophilia, Plavix use, active bleeding or prior reaction to warfarin or rivaroxaban, nursing mothers, hepatic disease, GFR \<30, use of more than 200mg of aspirin daily, and inability to continue medication or lab monitoring after hospital discharge known preoperatively.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Health Systems
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew G Urquhart, M.D.
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. Service Chief Clinical Associate Professor, Orthopaedic Surgery Hip and Knee Replacement
Study Record Dates
First Submitted
January 23, 2014
First Posted
February 4, 2014
Study Start
March 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
December 7, 2015
Record last verified: 2015-12