Comparison of Topical and Infusion Tranexamic Acid on Blood Loss and Risk of Deep Vein Thrombosis After Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of major bleeding after the first dose of rivaroxaban and all death related to postoperative bleedings
研究概览
简要总结
The purpose of the study, therefore, is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of TXA in different TKA patients groups with rivaroxaban for VTE prophylaxis, first group by topical application, second group by infusion and a third group of placebo and observe whether there is difference in the occurrence of venous thromboembolism in those patient groups by venographic study
详细描述
Investigators previous experiences in minimally invasive (MIS) TKA showed that intraoperative infusion of TXA reduced 45% of postoperative blood loss and needs for transfusion from 20% to 4%. However, most of the orthopedic surgeons still hesitate to use TXA systemically in TKAs especially in high risk patients with a potential increase in thromboembolic events following surgery.
Because of this concern, recently, there were few reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients. However, most of the reports compared the topical TXA with placebo in TKA patients, not with intravenous TXA. Recently, Georgiadis et al. conducted a double-blind, randomized controlled clinical trial are demonstrated similar transfusion rate and perioperative blood loss between topical administration and intravenous injection of TXA in TKA patients. There were no significant safety differences between the two groups. Low-molecular weight heparin (LMWH) was used for thromboembolism prophylaxis in that study.
Recently, chemical VTE prophylaxis such as rivaroxaban has been approved as a standard care after TKA because of its superior convenience and efficacy on VTE prophylaxis to LMWH in TKAs. However, because of direct blockage of the formation of thrombin from prothrombin by rivaroxaban, an increased postoperative bleeding has been reported. There have been little studies investigating the blood-conservation effect of TXA on TKA patients either by infusion or by topical application when rivaroxaban used as VTE 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
- 否
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
Topic TXA group
Primary total knee replacement with intravenous 0.9% normal saline (20 ml) administration before deflation of the tourniquet and intraarticular application of Tranexamic Acid 5%,5ml/amp 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
干预措施: Tranexamic Acid 5%,5ml/amp (Drug)
Topic TXA group
Primary total knee replacement with intravenous 0.9% normal saline (20 ml) administration before deflation of the tourniquet and intraarticular application of Tranexamic Acid 5%,5ml/amp 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
干预措施: rivaroxaban (10mg) (Drug)
Topic TXA group
Primary total knee replacement with intravenous 0.9% normal saline (20 ml) administration before deflation of the tourniquet and intraarticular application of Tranexamic Acid 5%,5ml/amp 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
干预措施: 0.9% Normal Saline (Drug)
IV TXA group
Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously before deflection of the tourniquet and topical 160 ml 0.9% normal saline application after closure of joint capsule.
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
干预措施: Tranexamic Acid 5%,5ml/amp (Drug)
IV TXA group
Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously before deflection of the tourniquet and topical 160 ml 0.9% normal saline application after closure of joint capsule.
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
干预措施: rivaroxaban (10mg) (Drug)
IV TXA group
Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously before deflection of the tourniquet and topical 160 ml 0.9% normal saline application after closure of joint capsule.
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
干预措施: 0.9% Normal Saline (Drug)
Control group
Primary total knee replacement with 0.9% normal saline administration intravenously before deflation of the tourniquet and topical 160 ml 0.9% normal saline application after closure of joint capsule.
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
干预措施: rivaroxaban (10mg) (Drug)
Control group
Primary total knee replacement with 0.9% normal saline administration intravenously before deflation of the tourniquet and topical 160 ml 0.9% normal saline application after closure of joint capsule.
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
干预措施: 0.9% Normal Saline (Drug)
结局指标
主要结局
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
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
次要结局
- Total blood loss after surgery(From the operation to the postoperative day 4)
- 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 ))
- 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
Wang Jun-Wen
Clinical Professor
Chang Gung Memorial Hospital