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

January 27, 2018 updated by: Supakit Kanitnate, Thammasat University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathum Thani
      • Klong Luang, Pathum Thani, Thailand, 12120
        • Thammasat University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose
single dose of intra-articular Tranexamic acid 500 miligrams
Drug: Tranexamic Acid
IA (intra-articular) tranexamic acid after capsule closure
Active Comparator: High dose
Single dose of intra-articular Tranexamic acid 3 grams
Drug: Tranexamic Acid
IA (intra-articular) tranexamic acid after capsule closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total blood loss
Time Frame: 72 hours after TKA
Blood loos that calculated from Haemoglobin drop at 72 hours after surgery
72 hours after TKA

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

January 29, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (Estimate)

February 6, 2017

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 27, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OrthoTU08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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