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

Blood Loss, Surgical Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044041
• Other study ID #: OrthoTU08
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2017
• Last updated: January 27, 2018
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: January 2018
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage

Intervention

Drug:
• Tranexamic Acid
IA (intra-articular) tranexamic acid after capsule closure

Locations

Country	Name	City	State
Thailand	Thammasat University	Klong Luang	Pathum Thani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total blood loss	Blood loos that calculated from Haemoglobin drop at 72 hours after surgery	72 hours after TKA
Secondary	Blood transfusion	incidence of blood transfusion after surgery	0-72 hours after surgery
Secondary	Rate of participants with thromboembolism	Clinical thromboembolism after surgery	At 72 hours and 2 weeks after surgery
Secondary	Rate of participants with infection	Superficial or deep infection after TKA	0-3 months after surgery
Secondary	Knee ROM	Range of motion of the knee	At 2, 6 weeks after surgery
Secondary	Functional score	Modified WOMAC	At 6 weeks after surgery