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NCT Number: NCT07494032

Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty

This study is a prospective double-blind randomized controlled trial to evaluate the effect of extended oral TXA after primary total TKA on short-term and mid-term postoperative outcomes, including function, pain, and postoperative complications over a 24-month period, with evaluations at 6 weeks, 3 months, 12 months, and 24 months. Each group of 175 patients will receive either extended oral TXA 1.95g daily or placebo for 7 days postoperatively. Function will be assessed by Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR) scores measured at all post operative time points as well as range of motion (ROM) (measured at all visits).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients are candidates for elective primary total knee arthroplasty.
  • Patients ≥18 years of age
  • Patients have been medically evaluated and scheduled for primary total knee arthroplasty.
  • Patients undergo primary total knee arthroplasty with spinal anesthesia
  • Patients receive 1g IV TXA prior to incision and 1g IV TXA at closure
  • Patients are prescribed aspirin 81mg twice a day for postoperative VTE prophylaxis

Exclusion criteria

  • Patients with an allergy to TXA
  • Patients taking a preoperative anticoagulant other than aspirin
  • Patients with a history of VTE
  • Patients with chronic kidney disease
  • Patients with active malignancy
  • Current use of combined hormonal contraception (pill, patch, or ring)
  • eGFR <60 mL/min/1.73 m² or other clinically significant renal impairment
  • Use of Factor IX complex concentrates, anti-inhibitor coagulant concentrates, or all-trans retinoic acid (tretinoin)
  • Anticipated need for tissue plasminogen activator (tPA) during the 7-day dosing period
  • Individuals who are pregnant or breastfeeding, have a positive pre operative pregnancy test, or plan pregnancy during the 7 day dosing window. Women of childbearing potential must have a negative pre operative pregnancy test and use effective contraception through postoperative day . Individuals who are on hormonal contraceptives or hormone replacement therapies, with the exception of Progestin, are to be excluded.

Treatment and study plan

Tranexamic acid (TXA)

Drug

Oral TXA 650mg dosed three times daily for 7 days, with a total dosage of 1.95g.

Placebo

Drug

Placebo administered at the same intervals as the oral TXA.

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) Score

    Time frame: Baseline, Week 6, Month 3, Month 12

    The KOOS, JR is a 7-item survey measuring overall knee health for individuals post total knee arthroplasty (TKA) by evaluating stiffness, pain, function, and activities of daily living. Each item is rated on a scale from 0-4; the total score is the sum of responses and ranges from 0-28; lower scores indicate more positive outcomes.

Secondary outcomes

  1. Knee Range of Motion (ROM): Flexion

    Time frame: Baseline, Week 6, Month 3, Month 12

    Assessed in degrees.

  2. Knee Range of Motion (ROM): Extension

    Time frame: Baseline, Week 6, Month 3, Month 12

    Assessed in degrees.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Warren

CONTACT

[email protected]

212-598-6245

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

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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