Comparison of Topical and Intravenous Tranexamic Acid on Blood Loss and Transfusion Rates in Total Hip Arthroplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Total Blood Loss（TBL）
研究概览
简要总结
Recently, there has been interest in applying tranexamic acid topically before the closure of surgical wounds in total hip replacement. It has the advantages of ease of application, maximum concentration at the site of bleeding, minimising its systematic absorption and, potentially , decline the risks for systematic side-effects 。
详细描述
Objectives:To assess the efficacy and safety between the two different applying routes.
Patients in this project are randomly divided into three groups , one group is a blank group and the rest two groups receive either the topical or the intravenous form of tranexamic acid during unilateral THA(total hip arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while the events of Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction 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 is clamped and closed completely for 2 hours; then the clamp is 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 hip arthroplasty Patients for Ruijin hospital, Shanghai, China
排除标准
- •Patients who refuse to sign the Inform Consent
- •Had an allergy to TXA.
- •long-term bed >=3 weeks.
- •Using anticoagulant drugs within a week.
- •Coagulopathy (preoperative platelet count <150,000/mm3, 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).
- •History of thromboembolic disease: .
- •Been participating or been participated within a year in another clinical trial
研究组 & 干预措施
Group1
60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the hip cavity for at least 3 minutes before wound closure and then sucked away.
干预措施: 0.9% sodium chloride (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' prior to skin incision 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 hip 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: estimated by an equation at the fifth postoperative day
Total Blood Loss（TBL） was estimated 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)
- Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism)(twelve weeks after surgery)
- drainage output(ti will be recorded at the first day and the second day after surgery)
- other thromboembolic event(twelve weeks after surgery)
研究者
zhoukaidi
MD in Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine