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.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Amount and character of wound drainage
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients over the age of 18 undergoing primary hip or knee replacement by Dr. Urquhart or Dr. Hallstrom.
排除标准
- •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.
研究组 & 干预措施
Rivaroxaban (Xarelto)
Rivaroxaban dosing will be 10mg once daily beginning on postoperative day 1 for a duration of 30 days.
干预措施: Rivaroxaban (Xarelto) (Drug)
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.
干预措施: Warfarin (Coumadin) (Drug)
结局指标
主要结局
Amount and character of wound drainage
时间窗: 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.
Number of days until a dry wound
时间窗: 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.
次要结局
- Incidence of wound infection(90 days)
- Number of days in the hospital postoperatively.(90 days)
- Incidence of additional operations(90 days)
研究者
Andrew Urquhart
M.D. Service Chief Clinical Associate Professor, Orthopaedic Surgery Hip and Knee Replacement
University of Michigan