Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty

NCT07494032 | Not Yet Recruiting

• 1 other identifier: 26-00007
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Knee Arthropathy

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, Week 6, Month 3, Month 12

Secondary Outcomes (2)

• Knee Range of Motion (ROM): Flexion

  Baseline, Week 6, Month 3, Month 12

• Knee Range of Motion (ROM): Extension

  Baseline, Week 6, Month 3, Month 12

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

Patients treated with tranexamic acid 1.95g per day for 7 days postoperative.

Drug: Tranexamic acid (TXA)

Placebo

PLACEBO COMPARATOR

Patients treated with placebo daily for 7 days postoperative.

Drug: Placebo

Interventions

Tranexamic acid (TXA) DRUG

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

Tranexamic Acid

Placebo DRUG

Placebo administered at the same intervals as the oral TXA.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Anna Cohen-Rosenblum, MD, MSc

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Warren

CONTACT

212-598-6245; Daniel.waren@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Daniel.waren@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US (1)