Status:
COMPLETED
Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Blood Loss
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 concentrat...
Detailed Description
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 g...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- Pregnancy
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT02312440
Start Date
October 1 2014
End Date
September 1 2015
Last Update
December 2 2015
Active Locations (1)
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1
Orthopedic Department of Ruijin hospital
Shanghai, Shanghai Municipality, China, 200001