Skip to main content
OpenTrials
Completed

NCT Number: NCT01850394

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Osteoarthritis of Knee Nos

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ramathibodi Hospital

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Tranexamic Acid

Drug

Inject tranexamic acid solution intra-articularly after fascia closure

Other names: Transmin

Physiologic saline

Drug

Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Primary outcomes

  1. 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

  2. Total Hemoglobin Loss

    Time frame: 5 days after surgery

    Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day

Secondary outcomes

  1. 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.

    • 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.

    • 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.

  2. Number of Patients Required Blood Transfusion

    Time frame: postoperative period (5 days after surgery)

  3. 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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
May 9, 2013
Registry last updated
Dec 13, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.