Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Arthropathy
• Intervention / Treatment: Drug: Tranexamic acid (TXA); Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Warren; Phone Number: 212-598-6245; Email: Daniel.waren@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic Acid; Patients treated with tranexamic acid 1.95g per day for 7 days postoperative.	Drug: Tranexamic acid (TXA); Oral TXA 650mg dosed three times daily for 7 days, with a total dosage of 1.95g.
Placebo Comparator: Placebo; Patients treated with placebo daily for 7 days postoperative.	Drug: Placebo; Placebo administered at the same intervals as the oral TXA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Range of Motion (ROM): Flexion	Assessed in degrees.	Baseline, Week 6, Month 3, Month 12
Knee Range of Motion (ROM): Extension	Assessed in degrees.	Baseline, Week 6, Month 3, Month 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Anna Cohen-Rosenblum, MD, MSc, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: 26-00007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Daniel.waren@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No