Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement

October 24, 2013 updated by: Viroj Kawinwonggowit, Mahidol University

Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement; A Prospective Triple-blinded Randomized Controlled Trial.

The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

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
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients diagnosed as primary knee osteoarthritis and underwent unilateral primary cemented conventional total knee replacement
  • no risk of abnormal bleeding tendency or bleeding disorder (normal coagulogram, serum creatinine < 2.0 mg/dL, stop nonsteroidal anti-inflammatory drugs and antiplatelet drugs more than 7 days
  • no contra-indication for tranexamic acid use (no active intravascular clotting process, no acquired defective colour vision, no subarachnoid hemorrhage, no hypersensitivity to TXA, and no any of history of serious adverse effects, thrombotic disorder and hematuria)

Exclusion Criteria:

  • incomplete data collection, for example, malfunctioned drain or accidental drain removal.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control group
physiologic saline 25 ml
Drug: Physiologic saline
Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
ACTIVE_COMPARATOR: TXA-250 group
A total of 25-ml solution with 250-mg tranexamic acid
Drug: Physiologic saline
Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Drug: Tranexamic Acid
Inject tranexamic acid solution intra-articularly after fascia closure
Other Names:
  • Transmin
ACTIVE_COMPARATOR: TXA-500 group
A total of 25-ml solution with 500-mg tranexamic acid
Drug: Physiologic saline
Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Drug: Tranexamic Acid
Inject tranexamic acid solution intra-articularly after fascia closure
Other Names:
  • Transmin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Blood Loss
Time Frame: 5 days after surgery
  • Drainage blood loss measured by accumulating total drainage volume postoperatively
  • Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day
5 days after surgery
Total Hemoglobin Loss
Time Frame: 5 days after surgery
Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day
5 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Function Scores
Time Frame: 1 year after surgery

Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period.

  1. Knee Society Knee Score using for rating knee function measurement and subdivided into two parts; knee score and function score 1.1. Knee score : calculated from pain, presence of deformity, total range of flexion, alignment, and stability. Total score is 100 (0-100), more score means better.

    1.2. Function score : calculated from patient's ability to walk and climb stairs. The score ranges from 0-100, more score means better.

  2. Western Ontario and McMaster Universities Arthritis Index or WOMAC score : a widely used, standardized questionnaires for evaluating the condition of patients with knee osteoarthritis, including pain (score = 0-20), stiffness (0-8), and functional limitation (0-68). Total score ranges from 0-68, lower score means better.
1 year after surgery
Number of Patients Required Blood Transfusion
Time Frame: postoperative period (5 days after surgery)
postoperative period (5 days after surgery)
Number of Patients Having Postoperative Complications
Time Frame: postoperative 1-year period

Postoperative complications were measured as an incidence of the following complications;

  • wound hematoma
  • surgical site infection
  • systemic infection
  • deep vein thrombosis
  • pulmonary embolism
  • knee stiffness requiring manipulation
  • medical complication such as myocardial infarction, congestive hear failure
postoperative 1-year period

Collaborators and Investigators

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

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (ESTIMATE)

May 9, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID 01-53-06

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.

Clinical Trials on Primary Osteoarthritis of Knee Nos

Clinical Trials on Physiologic saline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe