Knee ArthropathyNCT07494032
Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty
A study testing Tranexamic acid (TXA) in people with Knee Arthropathy, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Tranexamic acid (TXA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
- Conditions
- Knee Arthropathy
- Being tested
- Tranexamic acid (TXA), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid (TXA)Drug
Oral TXA 650mg dosed three times daily for 7 days, with a total dosage of 1.95g.
PlaceboDrug
Placebo administered at the same intervals as the oral TXA.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | Patients treated with tranexamic acid 1.95g per day for 7 days postoperative. Receives: Drug: Tranexamic acid (TXA) |
| Placebo | Placebo comparator | Patients treated with placebo daily for 7 days postoperative. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 6, Month 3, Month 12
Secondary outcomes (2)
Knee Range of Motion (ROM): Flexion
Assessed in degrees.
Measured: Baseline, Week 6, Month 3, Month 12
Knee Range of Motion (ROM): Extension
Assessed in degrees.
Measured: Baseline, Week 6, Month 3, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Cohen-Rosenblum, MD, MSc, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494032
- Sponsor's protocol ID
- 26-00007
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07494032
- Acronym / sponsor ID
- 26-00007
- Conditions
- Knee Arthropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: Tranexamic acid (TXA)Patients treated with tranexamic acid 1.95g per day for 7 days postoperative. |
| Placebo | Placebo comparator | Drug: PlaceboPatients treated with placebo daily for 7 days postoperative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid (TXA)Oral TXA 650mg dosed three times daily for 7 days, with a total dosage of 1.95g. | Drug | Tranexamic Acid |
| PlaceboPlacebo administered at the same intervals as the oral TXA. | Drug | Placebo |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) Score
Time frame: Baseline, 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.
2 secondary outcomes
Knee Range of Motion (ROM): Flexion
Time frame: Baseline, Week 6, Month 3, Month 12
Knee Range of Motion (ROM): Extension
Time frame: Baseline, Week 6, Month 3, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Knee Arthropathy
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Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Cohen-Rosenblum, MD, MSc principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid (TXA) in people with Knee Arthropathy, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Warren (212-598-6245, Daniel.waren@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) Score (time frame: Baseline, Week 6, Month 3, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.