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Completed

NCT Number: NCT03044041

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

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

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Key information

Conditions

Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thammasat University

Klong Luang, Changwat Pathum Thani, 12120, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

IA (intra-articular) tranexamic acid after capsule closure

Primary outcomes

  1. Total blood loss

    Time frame: 72 hours after TKA

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 6, 2017
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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