Complications; Arthroplasty | Evaluation of Wound Drainage After Knee or Hip Arthroplasty
Complications; Arthroplasty research study
What is the primary objective of this 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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
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.
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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Rivaroxaban (Xarelto)Rivaroxaban dosing will be 10mg once daily beginning on postoperative day 1 for a duration of 30 days.
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.
Start Date: March 2014
Completed Date: February 2016
Phase: Phase 4
Primary Outcome: Number of days until a dry wound
Secondary Outcome: Number of days in the hospital postoperatively.
Study sponsors, principal investigator, and references
Principal Investigator: Andrew G Urquhart, M.D.
Lead Sponsor: University of Michigan