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Extended Oral Tranexamic Acid After Total Knee Replacement

This study is looking at whether taking extended oral tranexamic acid (TXA) after total knee replacement surgery helps with recovery. TXA is a medication that helps reduce bleeding. You would be randomly assigned to receive either oral TXA (650mg three times a day for 7 days) or a placebo (an inactive pill) after your surgery. All participants will also receive IV TXA during surgery and aspirin afterward. The study aims to see how well you recover in terms of function, pain, and complications over 24 months. We'll measure this using a score called the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR). To join, you must be at least 18 years old, scheduled for a primary total knee replacement, and meet other medical criteria. The study plans to enroll 350 participants.

Study design
This is a randomized, double-blind study with 350 participants. You would be randomly assigned to one of two groups: extended oral TXA or a placebo.
What's involved
You would take either oral TXA or a placebo for 7 days after your surgery. Your knee function and range of motion will be checked at 6 weeks, 3 months, 12 months, and 24 months after surgery.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 24 months after your surgery, with evaluations at 6 weeks, 3 months, 12 months, and 24 months.

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NCT07494032

Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
NYU Langone Health
~350 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:Tranexamic acid (TXA)Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) Score
Measured over Baseline, Week 6, Month 3, Month 12

Conditions

Knee Arthropathy

Explore related trials

Total Knee Replacement

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Anna Cohen-Rosenblum, MD, MSc · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Daniel Warren
[email protected]
212-598-6245
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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