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Completed

NCT Number: NCT04443920

Tranexamic Acid for Total Knee Arthroscopy

The purpose of this investigation is to determine the most effective regimen of administration of tranexamic acid to improve clinical outcome among patients undergoing total knee arthroplasty.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Miriam Hospital

Providence, Rhode Island, 02903, United States

About this study

Tranexamic acid (TXA) is synthetic lysine analog, which acts as anti-fibrinolytic agent by preventing conversion of plasminogen in to plasmin. Various regimens of TXA administration (routes, doses, timing) have been used to decrease perioperative blood loss and improve clinical outcomes among patients undergoing different orthopedic surgeries. We are conducting this prospective randomized placebo controlled trial to compare the effect of the two most common regimens of TXA administration on hemostasis and clinical outcomes among patients undergoing total knee arthroplasty. All recruited patients receive the first dose of 15mg/kg of IV TXA prior to skin incision. The second dose of 15mg/kg IV TXA or identical placebo is administered prior to the release of the tourniquet.

The assessment of hemostasis is performed using whole blood sample via viscoelastic testing by rotational thromboelastography (ROTEM). A blood sample is collected in the preoperative area and after the administration of each dose of TXA. Clinical data is collected until 90 days after surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients who are scheduled to undergo total knee arthroplasty will be approached to participate.

Exclusion criteria

  • Known allergy to TXA
  • History of venous or arterial thrombosis within 12 months
  • History of thromboembolic event within 12 months
  • Acute ischemic event (stroke, transient ischemic attack, myocardial infarction, ischemic retinopathy) within 6 months
  • Known congenital thrombophilia

Relative Contraindications:

  • History of seizures
  • Impaired kidney function (Glomerular filtration rate < 30 ml/min)

Treatment and study plan

Tranexamic acid (TXA)

Drug

Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups

Other names: Lysteda, Cyklokapron

Placebo Normal Saline (NS)

Drug

Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups

Other names: Sodium chloride

Primary outcomes

  1. Assessment of changes in hemostasis via viscoelastic testing.

    Time frame: intraoperative (min)

    To compare the magnitude of lysis via lysis indexes.

Secondary outcomes

  1. Hematocrit

    Time frame: postoperative day 1

    The comparison of hematocrit recordings from preoperative period to the postoperative period

  2. Length of Hospitalization

    Time frame: up to 7 days

    Length of hospital stay from day of surgery to discharge from hospital.

  3. The number of blood transfusions

    Time frame: 90 days

    The number of blood products transfused after surgery

  4. Hospital readmissions

    Time frame: 90 days

    The occurrence of hospital readmissions following surgery

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Official study title

Comparison of the Effect of Two Common Regimens of Administration of Tranexamic Acid on Hemostasis and Clinical Outcome of Patients Undergoing Total Knee Arthroplasty

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jun 23, 2020
Registry last updated
Jun 22, 2023

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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