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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Topical Intra‐Articular High Doses Compared With Low Doses of Tranexamic Acid to Reduce Blood Loss in Primary Total Knee Arthroplasty: A Double‐Blind Randomized Controlled Trial

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 Summary:
Sponsor: Thammasat University

Current Primary Outcome: Total blood loss [ Time Frame: 72 hours after TKA ]

Blood loos that calculated from Haemoglobin drop at 72 hours after surgery


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Thammasat University

Dates:
Date Received: January 29, 2017
Date Started: December 2016
Date Completion: September 2017
Last Updated: February 2, 2017
Last Verified: February 2017