Comparison of Topical Versus Intravenous Tranexamic Acid in Primary Total Knee Arthroplasty：A Prospective Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Total Blood Loss（TBL）
研究概览
简要总结
Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate largely without major complications . In addition, many meta-analyses have confirmed these results . However, there is little information about comparison among the different routes of TXA administration in TKA. Therefore, this study has been designed to determine which administration route of TXA is more effective and safety.
详细描述
Objectives:To assess the efficacy and safety between the two different applying routes.
Patients in this project will be randomly divided into three groups , one group is a blank group and the rest two receive either the topical or the intravenous form of tranexamic acid during unilateral TKA(total knee arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction events will be recorded to assess the safety of the tranexamic acid during a six-week follow-up for each patient.
All surgery are under general anesthesia, through direct lateral approach with cementless prosthesis.For all patients, the drain tube will be clamped and closed completely for 2 hours; then the clamp will be fully opened.
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
- Triple (Participant, Care Provider, 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
- •Consented to join in our project.
- •Adult patients (greater than 18 years old)
- •Patients scheduled for primary unilateral knee arthroplasty
排除标准
- •Patients who refuse to sign the Inform Consent
- •Had an allergy to TXA.
- •Using anticoagulant drugs within a week.
- •Coagulopathy (preoperative platelet count <150,000/mm3,International Sensitivity Index（INR）>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time >1.4 times longer than normal.
- •Breastfeeding
- •Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; renal dysfunction ( glomerular filtration rate<60); or hepatic disfunction(glutamic-pyruvic transaminase>80 or glutamic oxalacetic transaminase>80).Retinopathy (disturbances of color vision).
- •9.History of thromboembolic disease
研究组 & 干预措施
Group1
60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away.
干预措施: normal saline (Drug)
Group2
two-dose intravenous tranexamic acid will be applied as follow: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride),the first dose 15' before the tourniquet deflation and the second dose at 180' after the first dosage
干预措施: Tranexamic Acid (Drug)
Group 3
3g Tranexamic Acid diluted to 60 Milliliters（ml） with normal saline (0.9% sodium chloride) will be applied by soaking the knee cavity for at least 3 minutes before wound closure and then sucked away.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Total Blood Loss（TBL）
时间窗: calculated by an equation at the fifth postoperative day
Total Blood Loss（TBL） was calculated with equations described by Gross et al.
次要结局
- Transfusion rates(from the day of surgery to the day of discharge,an expected average of 7 days)
研究者
zhoukaidi
MD in Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine