Comparison Between Low Dose and High Dose Intra-articular Tranexamic Acid in Total Knee Arthroplasty

Phase 4

Completed

• Conditions: Blood Loss, Surgical
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT03044041
• Lead Sponsor: Thammasat University

Brief Summary

The purpose of this study is to compare blood loss between using low dose (500 mg) and high dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in double-blind RCT

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2017-01
• Study First Submitted: 2017-01-29
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-06
• Study Completion: 2017-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-27
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Osteoarthritic knee who underwent primary total knee arthroplasty

Exclusion Criteria

• Abnormal coagulation or bleeding disorder
• Allergy to tranexamic acid
• History of thromboembolism or ischemic heart disease or cerebrovascular accident
• chronic kidney disease stage 3-4

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	Tranexamic Acid	single dose of intra-articular Tranexamic acid 500 miligrams
High dose	Tranexamic Acid	Single dose of intra-articular Tranexamic acid 3 grams

Primary Outcome Measures

Name	Time	Method
Total blood loss	72 hours after TKA	Blood loos that calculated from Haemoglobin drop at 72 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Functional score	At 6 weeks after surgery	Modified WOMAC
Rate of participants with infection	0-3 months after surgery	Superficial or deep infection after TKA
Blood transfusion	0-72 hours after surgery	incidence of blood transfusion after surgery
Rate of participants with thromboembolism	At 72 hours and 2 weeks after surgery	Clinical thromboembolism after surgery
Knee ROM	At 2, 6 weeks after surgery	Range of motion of the knee

Trial Locations

Locations (1)

Thammasat University; 🇹🇭 Klong Luang, Pathum Thani, Thailand