Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty (NCT07494032) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty
United States350 participantsStarted 2026-05-01
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) Score