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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03044041
Recruitment Status : Completed
First Posted : February 6, 2017
Last Update Posted : January 30, 2018
Information provided by (Responsible Party):
Supakit Kanitnate, 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

Condition or disease Intervention/treatment Phase
Blood Loss, Surgical Drug: Tranexamic Acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Total blood loss [ Time Frame: 72 hours after TKA ]
    Blood loos that calculated from Haemoglobin drop at 72 hours after surgery

Secondary Outcome Measures :
  1. Blood transfusion [ Time Frame: 0-72 hours after surgery ]
    incidence of blood transfusion after surgery

  2. Rate of participants with thromboembolism [ Time Frame: At 72 hours and 2 weeks after surgery ]
    Clinical thromboembolism after surgery

  3. Rate of participants with infection [ Time Frame: 0-3 months after surgery ]
    Superficial or deep infection after TKA

  4. Knee ROM [ Time Frame: At 2, 6 weeks after surgery ]
    Range of motion of the knee

  5. Functional score [ Time Frame: At 6 weeks after surgery ]
    Modified WOMAC

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03044041

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Thammasat University
Klong Luang, Pathum Thani, Thailand, 12120
Sponsors and Collaborators
Thammasat University

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Responsible Party: Supakit Kanitnate, Investigator, Thammasat University Identifier: NCT03044041    
Other Study ID Numbers: OrthoTU08
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Supakit Kanitnate, Thammasat University:
Blood loss
Tranexamic acid
Total knee arthroplasty
Topical administration
Additional relevant MeSH terms:
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Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action