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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Complications; Arthroplasty
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto); Drug: Warfarin (Coumadin)

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health Systems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients over the age of 18 undergoing primary hip or knee replacement by Dr. Urquhart or Dr. Hallstrom.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rivaroxaban (Xarelto); Rivaroxaban dosing will be 10mg once daily beginning on postoperative day 1 for a duration of 30 days.	Drug: Rivaroxaban (Xarelto); To date there has been little attention to evaluating differences in wound complications following TJA among patients treated with rivaroxaban compared to warfarin.
Active Comparator: Warfarin (Coumadin); Warfarin 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.	Drug: Warfarin (Coumadin); To date there has been little attention to evaluating differences in wound complications following TJA among patients treated with rivaroxaban compared to warfarin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days in the hospital postoperatively.	How many days patient is in hospital postoperatively will be noted	90 days
Incidence of wound infection	Presence or absence of clinical infection will be noted according to ASEPSIS criteria.	90 days
Incidence of additional operations	Additional operations include irrigation and debridement and or revision	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey assessments	Satisfaction and activity combined scores from the UCLA Activity Score and the PROMIS Survey at 90 days will be compared to UCLA Activity Score and PROMIS Survey at preoperative visit	90 days

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Andrew G Urquhart, M.D., University of Michigan

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: February 3, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Estimate): December 7, 2015
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Warfarin
• Other Study ID Numbers: HUM00062541