Complications; Arthroplasty
Conditions
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.
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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days until a dry wound | 90 days | 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. |
| Amount and character of wound drainage | 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days in the hospital postoperatively. | 90 days | How many days patient is in hospital postoperatively will be noted |
| Incidence of wound infection | 90 days | Presence or absence of clinical infection will be noted according to ASEPSIS criteria. |
| Incidence of additional operations | 90 days | Additional operations include irrigation and debridement and or revision |
Other
| Measure | Time frame | Description |
|---|---|---|
| Survey assessments | 90 days | 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 |
Countries
United States
Outcome results
None listed