Comparison of Topical Versus Intravenous Tranexamic Acid in TKA
- Registration Number
- NCT02393300
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
- Consented to join in our project.
- Adult patients (greater than 18 years old)
- Patients scheduled for primary unilateral knee arthroplasty
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group1 normal saline 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. Group 3 Tranexamic Acid 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. Group2 Tranexamic Acid 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
- Primary Outcome Measures
Name Time Method Total Blood Loss（TBL） calculated by an equation at the fifth postoperative day Total Blood Loss（TBL） was calculated with equations described by Gross et al.
- Secondary Outcome Measures
Name Time Method Transfusion rates from the day of surgery to the day of discharge,an expected average of 7 days Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay
Trial Locations
- Locations (1)
Orthopedic Department of Ruijin hospital
🇨🇳Shanghai, Shanghai, China