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临床试验/NCT02458729
NCT02458729已完成4 期

The Blood Saving Effect and Wound-related Complications of Tranexamic Acid in Mininally Invasive Total Knee Arthroplasty With Rivaroxaban as Thromboprophylaxis

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
294
试验地点
1
主要终点
Incidence of any deep-vein thrombosis, non-fatal pulmonary embolism, or all-cause mortality

研究概览

简要总结

The aim of this study was to conduct a prospective, randomized, double-blind study and assess the efficacy of and safety for thromboprophylaxis of rivaroxaban in total knee arthroplasty patients when tranexamic acid is used for bleeding prophylaxis.

详细描述

Total knee arthroplasty is an effective procedure for end-stage arthritis of the knee in terms of pain relief and functional recovery. However, this procedure is associated with a substantial perioperative blood loss. As high as 69% allogeneic blood transfusion rate was reported in patients receiving total knee arthroplasty when preoperative haemoglabin level was <13 g/dl. Tranexamic acid (TXA), an antifibrinolytic, given intraoperatively, has been reported to be effective in reducing one third of postoperative blood loss in standard total knee arthroplasty. Our previous study showed that TXA reduced total blood loss from 1453mL to 833mL (p<0.001) and the need for transfusion from 20% to 4% (p=0.014) in total knee patients with enoxaparin (Clexane; Glaxo-Smith-Kline, Brentford, United Kindom) for thromboprophylaxis.

In recent years, there have been more effective and practical methods for thrombophylaxis in total hip and knee replacement surgeries. Rivaroxaban is one of the first oral factor Xa inhibitors licensed for this regard. The advantages of rivaroxaban include oral administration, no need to monitor blood levels and no dosing adjustments which are convenient for short hospital stay in contemporary total knee arthroplasty. Its efficacy in preventing venous thromboembolism (VTE) after total knee arthroplasty have been extensitvely investigated in RECORD (Regulation of Coagulation in Orthopaedic surgery to prevent Deep-vein thrombosis and pulmonary embolism) 3 and 4 studies, and the results showed that rivaroxaban 10mg once daily was superior to enoxaparin 40mg subcutaneously once daily or 30mg every 12 hours for 10 to 14 days. Despite of its clinical efficacy in VTE prophylaxis, orthopaedic surgeons are still sceptic in routine use of rivaroxaban in knee and hip surgery and concerned about the increased risk of bleeding complications. A higher reoperation rate regarding wound complications within 30 days of hip and knee replacement in the rivaroxaban group than the tinzaparin group (2.94% versus 1.8%) was reported recently. Similar event has been reported in other studies. However, all these studies did not use TXA as bleeding prophylaxis after hip and knee replacement surgery. The risk of increasing VTE by use of TXA, owing to its antifibrinolytic effects, is the cause of concern.

The aim of this study was to conduct a prospective, randomized, double-blind study and assess the efficacy of and safety for thromboprophylaxis of rivaroxaban in total knee arthroplasty patients when TXA is used for bleeding prophylaxis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • End-stage arthritis of the knee
  • Failure of medical treatment or rehabilitation
  • Hemoglobin > 10g/dl
  • No use of non-steroid anti-inflammatory agent one week before operation

排除标准

  • Preoperative Hemoglobin ≦10 g/dl
  • History of infection or intraarticular fracture of the affective knee
  • Renal function deficiency (GFR < 55 ml/min/1.73m2)which is relative contraindicated for venography
  • Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy (including long-term use anticoagulant)
  • History of deep vein thrombosis, ischemic heart disease or stroke

研究组 & 干预措施

Placebo Group

Placebo Comparator

Primary total knee replacement with 0.9% normal saline 20ml administration intravenously twice, five minutes before deflation of the tourniquet and 3 hours after operation Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis

干预措施: 0.9% Normal Saline (intraoperative) (Drug)

Placebo Group

Placebo Comparator

Primary total knee replacement with 0.9% normal saline 20ml administration intravenously twice, five minutes before deflation of the tourniquet and 3 hours after operation Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis

干预措施: 0.9% Normal Saline (3 hours after operation) (Drug)

Placebo Group

Placebo Comparator

Primary total knee replacement with 0.9% normal saline 20ml administration intravenously twice, five minutes before deflation of the tourniquet and 3 hours after operation Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis

干预措施: rivaroxaban (10mg) (Drug)

One-dose TXA Group

Active Comparator

Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously five minutes before deflation of the tourniquet. and then 0.9% normal saline 20ml administration intravenously 3 hours after operation Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis

干预措施: Tranexamic Acid 5%,5ml/amp (intraoperative) (Drug)

One-dose TXA Group

Active Comparator

Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously five minutes before deflation of the tourniquet. and then 0.9% normal saline 20ml administration intravenously 3 hours after operation Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis

干预措施: 0.9% Normal Saline (3 hours after operation) (Drug)

One-dose TXA Group

Active Comparator

Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously five minutes before deflation of the tourniquet. and then 0.9% normal saline 20ml administration intravenously 3 hours after operation Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis

干预措施: rivaroxaban (10mg) (Drug)

Two-dose TXA Group

Active Comparator

Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously twice, five minutes before deflation of the tourniquet and 3 hours after operation Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis

干预措施: Tranexamic Acid 5%,5ml/amp (intraoperative) (Drug)

Two-dose TXA Group

Active Comparator

Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously twice, five minutes before deflation of the tourniquet and 3 hours after operation Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis

干预措施: Tranexamic Acid 5%,5ml/amp (3 hours after operation) (Drug)

Two-dose TXA Group

Active Comparator

Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously twice, five minutes before deflation of the tourniquet and 3 hours after operation Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis

干预措施: rivaroxaban (10mg) (Drug)

结局指标

主要结局

Incidence of any deep-vein thrombosis, non-fatal pulmonary embolism, or all-cause mortality

时间窗: within 15 days after surgery (2 days after the last dose of rivaroxaban )

Primary efficacy outcome is the composite of any deep-vein thrombosis, non-fatal pulmonary embolism, or all-cause mortality

Incidence of major bleeding after the first dose of rivaroxaban and all death related to postoperative bleedings

时间窗: within 15 days after surgery (2 days after the last dose of rivaroxaban )

Primary safety outcome is the composite of major bleeding after the first dose of rivaroxaban and all death related to postoperative bleedings. Major bleeding was defined as bleeding that was fatal, that involved a critical organ, or that required reoperation or clinically overt bleeding outside the surgical site that was associated with a decrease in the hemoglobin level of 2 g or more per deciliter or requiring infusion of 2 or more units of blood

次要结局

  • Incidence of wound complications after surgery(within 30 days of the procedure)
  • Incidence of major venous thromboembolism(within 15 days after surgery (2 days after the last dose of rivaroxaban)
  • Total blood loss after surgery(From the operation to the postoperative day 4)
  • Secondary safety outcome was composite of any non-major bleeding and all wound complications after operation(within 15 days after surgery (2 days after the last dose of rivaroxaban)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang Jun-Wen

Clinical Professor

Chang Gung Memorial Hospital

研究点 (1)

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