Oral Tranexamic Acid After Total Knee Arthroplasty

NCT06894719 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 25031706
• Study Type: interventional
• Target: 351
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, double-blind, randomized controlled trial evaluating the efficacy of oral tranexamic acid (TXA) in total knee arthroplasty (TKA). The study will assess pain, function, and range of motion (ROM) over a 2-year period, with key evaluations at 6 weeks and 90 days postoperatively. Hypothesis: Patients receiving 1.95g oral TXA for 3 or 7 days post-op will show improved pain, function, and ROM at 6 weeks and 90 days, with similar blood loss and transfusion rates as the control group.

Conditions

Total Knee Arthroplasty

Keywords

tranexamic acid; range of motion; postoperative pain; postoperative function

Outcome Measures

Primary Outcomes (1)

• Primary endpoint: knee range of motion

  Primary Endpoint: Knee ROM

  (flexion/extension) at 2 weeks and 6 weeks post op

Secondary Outcomes (4)

• Secondary" VAS pain scores

  2 weeks, 6 weeks, and 3 months post op

• Secondary: KOOS Jr

  2 weeks. 6 weeks, 3 months post op

• secondary: EQ-5D-3L functional scores

  2 weeks, 6 weeks, and 3 months post op

• Adverse events and complications

  3 months post op

Study Arms (3)

Oral-Short Arm: 1.95g TXA daily POD 1-3

ACTIVE COMPARATOR

1.95g TXA daily for post operative days 1-3

Drug: tranexamic acid Oral-Short Arm

Oral-Long Arm

ACTIVE COMPARATOR

1.95g TXA daily for post operative days 1-7

Drug: tranexamic acid Oral-Long Arm

Control Group: Placebo for 3 days post-op

PLACEBO COMPARATOR

Placebo for 3 days post-op

Drug: Control group placebo

Interventions

tranexamic acid Oral-Short Arm DRUG

1.95g Tranexamic acid daily for post op days 1 to 3

Oral-Short Arm: 1.95g TXA daily POD 1-3

tranexamic acid Oral-Long Arm DRUG

1.95g tranexamic acid daily post op days 1-7

Oral-Long Arm

Control group placebo DRUG

Placebo for 3 days post-op

Control Group: Placebo for 3 days post-op

Eligibility Criteria

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

You may qualify if:

• Any patient undergoing primary TKA at Rush main hospital or participating ASC
• Willingness to undergo randomization to take medication potentially up to 7 days post op.
• Willing to answer daily questions on pain, functionality and opioid consumption

You may not qualify if:

• History of venous thromboembolism, MI, or stroke in the past year
• Patients on any chronic anticoagulation medications besides Aspirin
• Patients with Cancer
• Patients with end stage renal disease that are on dialysis
• Drug allergy to TXA
• Taking oral birth control
• Unable to provide consent

Sponsors & Collaborators

• Rush University Medical Center: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Bailey Terhune, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne DeBenedetti, MSc

CONTACT

13124322468; anne.debenedetti@rushortho.com

Marisa Toschi, BS

CONTACT

312-432-2455; marisa.toschi@rushortho.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Patients will be randomized via computer-generated assignment and remain blinded to treatment. Data collection includes ROM assessments at follow-ups, surveys, and chart reviews for complications. This study aims to optimize oral TXA dosing in TKA to improve recovery while maintaining safety and cost-effectiveness.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months following end of study and will last for a year
• Access Criteria: unending