Osteoarthritis (OA) of the HipPhase 4NCT07685743
Extended Post-operative Oral TXA in Primary THA
A Phase 4 study testing Extended oral tranexamic acid regimen in people with Osteoarthritis (OA) of the Hip and Osteoarthritis (OA) of the Knee, run by Oregon Health and Science University.
Trial summary
The goal of this clinical trial is to learn if extended post-operative oral tranexamic acid (TXA) - a medication that reduces bleeding by slowing the breakdown of blood clots - can improve functional recovery following surgery in adults undergoing primary total knee or hip arthroplasty for osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Knee
- What is being tested?
- Extended oral tranexamic acid regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Phase 4
- 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
- Age ≥18 years
- Undergoing primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis
- Ability to provide written informed consent
- Willingness to comply with study protocol
Who cannot join
- History of venous thromboembolism (DVT or PE)
- Active malignancy
- Allergy or contraindication to tranexamic acid (TXA)
- Post-operative anticoagulation therapy other than aspirin
- History of color blindness or retinal disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Extended Post-operative Oral TXA vs.Standard Perioperative TXA in Primary TJA: A Randomized, Double-Blind, Placebo-Controlled Trial
The goal of this clinical trial is to learn if extended post-operative oral tranexamic acid (TXA) - a medication that reduces bleeding by slowing the breakdown of blood clots - can improve functional recovery following surgery in adults undergoing primary total knee or hip arthroplasty for osteoarthritis. The main question it aims to answer is: Does extended post-operative oral TXA improve functional outcomes at 6 weeks post-operatively compared to standard perioperative TXA alone? Researchers will compare patients receiving extended oral TXA to patients receiving matching placebo capsules on the same schedule to see if the extended TXA regimen reduces blood loss, improves early functional outcomes, and reduces pain without increasing complication rates. Participants will receive standard perioperative oral TXA (1.95 g) prior to surgical incision, along with standard VTE prophylaxis. They will be randomly assigned to receive either oral TXA or matching placebo capsules once daily on post-operative days 1, 2, and 3. Participants will attend follow-up visits at 2, 6, and 12 weeks post-operatively to complete functional outcome questionnaires, pain assessments, and - for knee replacement patients - range of motion measurements.
- Being tested
- Extended oral tranexamic acid regimen, Placebo
- Keywords
- Tranexamic acid, Patient Reported Outcomes, Arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended oral tranexamic acid regimenDrug
Participants in the intervention group will receive 1.95mg of oral tranexamic acid on post-operative day 1, 2, and 3.
PlaceboDrug
Patients will receive an oral placebo medication on post-operative day 1, 2, and 3.
| Study group | Role | What they receive |
|---|---|---|
| Extended Oral TXA | Experimental | Participants will receive standard 1.95mg pre-operative oral TXA dose in addition to 1.95mg oral TXA on post-operative days 1, 2, and 3. Receives: Drug: Extended oral tranexamic acid regimen |
| Placebo | Placebo comparator | Patients will receive standard pre-operative 1.95mg oral TXA, followed by a placebo pill on post-operative days 1, 2 and 3. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 6 weeks post-operatively. Scale for booth outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
Measured: At 6 weeks from timing of surgical intervention
Secondary outcomes (15)
2-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 2 weeks post-operatively. Scale for both outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
Measured: At 2 weeks from timing of surgical intervention
12-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 12 weeks post-operatively. Scale for both outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
Measured: At 12 weeks from timing of surgical intervention
2-week Visual Analog Scale (VAS) pain score
Visual analog scale (VAS) pain score at 2 weeks post-operatively. Scale is 0-10 with higher scores representing more pain.
Measured: At 2 weeks from timing of surgical intervention
6-week Visual Analog Scale (VAS) pain score
Visual analog scale (VAS) pain score at 6 weeks post-operatively. Scale is 0-10 with higher scores representing more pain.
Measured: At 6 weeks from timing of surgical intervention
12-week Visual Analog Scale (VAS) pain score
Visual analog scale (VAS) pain score at 12 weeks post-operatively. Scale is 0-10 with higher scores representing more pain.
Measured: At 12 weeks from timing of surgical intervention
6-week absolute knee flexion
Degrees of knee flexion achieved at the 6 week post-operative mark for patients undergoing Total Knee Arthroplasty
Measured: At 6 weeks from timing of surgical intervention
Transfusion rate
Percentage of patients per arm requiring post-operative transfusion of blood products
Measured: From enrollment to end of treatment at 12 weeks from timing of surgical intervention
Blood product units transfused
For each arm, the average number of blood product units transfused per patient
Measured: From enrollment to end of treatment at 12 weeks from timing of surgical intervention
Incidence of Symptomatic DVT
The number of post-operative symptomatic deep vein thromboses identified in each arm
Measured: From enrollment to end of treatment at 90 days from timing of surgical intervention
Incidence of Symptomatic PE
The number of post-operative symptomatic pulmonary embolisms identified in each arm
Measured: From enrollment to end of treatment at 90 days from timing of surgical intervention
Incidence of Acute Coronary Sndrome
The number of cases of post-operative acute coronary syndrome, defined as an ST-elevation myocardial infarction (STEMI), a non-ST-elevation myocardial infarction (NSTEMI), or unstable angina.
Measured: From enrollment to end of treatment at 90 days from timing of surgical intervention
Incidence of Cerebrovascular Accident
The number of post-operative cerebrovascular accidents (CVAs), defined as ischemic or hemorrhagic stroke.
Measured: From enrollment to end of treatment at 90 days from timing of surgical intervention
Rate of Readmission
The number of patients per arm requiring readmission for any reason within 90 days of surgical intervention.
Measured: From enrollment to end of treatment at 12 weeks from timing of surgical intervention
Rate of Reoperation
The number of patients per arm requiring reoperation for any indication within 90 days of surgical intervention.
Measured: From enrollment to end of treatment at 90 days from timing of surgical intervention
All-cause Mortality Rate
The number of patients deceased of any cause within 90 days of surgical intervention.
Measured: From enrollment to end of treatment at 90 days from timing of surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the HipStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryland Kagan, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685743
- Sponsor's protocol ID
- 30119
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Post-operative Oral TXA vs.Standard Perioperative TXA in Primary TJA: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07685743
- Acronym / sponsor ID
- 30119
- Keywords
- Tranexamic acid, Patient Reported Outcomes, Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 6 Jul 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.
The goal of this clinical trial is to learn if extended post-operative oral tranexamic acid (TXA) - a medication that reduces bleeding by slowing the breakdown of blood clots - can improve functional recovery following surgery in adults undergoing primary total knee or hip arthroplasty for osteoarthritis. The main question it aims to answer is: Does extended post-operative oral TXA improve functional outcomes at 6 weeks post-operatively compared to standard perioperative TXA alone? Researchers will compare patients receiving extended oral TXA to patients receiving matching placebo capsules on the same schedule to see if the extended TXA regimen reduces blood loss, improves early functional outcomes, and reduces pain without increasing complication rates. Participants will receive standard perioperative oral TXA (1.95 g) prior to surgical incision, along with standard VTE prophylaxis. They will be randomly assigned to receive either oral TXA or matching placebo capsules once daily on post-operative days 1, 2, and 3. Participants will attend follow-up visits at 2, 6, and 12 weeks post-operatively to complete functional outcome questionnaires, pain assessments, and - for knee replacement patients - range of motion measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Oral TXA | Experimental | Drug: Extended oral tranexamic acid regimenParticipants will receive standard 1.95mg pre-operative oral TXA dose in addition to 1.95mg oral TXA on post-operative days 1, 2, and 3. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive standard pre-operative 1.95mg oral TXA, followed by a placebo pill on post-operative days 1, 2 and 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Undergoing primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis
- Ability to provide written informed consent
- Willingness to comply with study protocol
Key exclusion criteria (5 listed)
- History of venous thromboembolism (DVT or PE)
- Active malignancy
- Allergy or contraindication to tranexamic acid (TXA)
- Post-operative anticoagulation therapy other than aspirin
- History of color blindness or retinal disease
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 |
|---|---|---|
| Extended oral tranexamic acid regimenParticipants in the intervention group will receive 1.95mg of oral tranexamic acid on post-operative day 1, 2, and 3. | Drug | Extended Oral TXA |
| PlaceboPatients will receive an oral placebo medication on post-operative day 1, 2, and 3. | Drug | Placebo |
Primary outcome
6-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Time frame: At 6 weeks from timing of surgical intervention
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 6 weeks post-operatively. Scale for booth outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
15 secondary outcomes
2-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Time frame: At 2 weeks from timing of surgical intervention
12-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Time frame: At 12 weeks from timing of surgical intervention
2-week Visual Analog Scale (VAS) pain score
Time frame: At 2 weeks from timing of surgical intervention
6-week Visual Analog Scale (VAS) pain score
Time frame: At 6 weeks from timing of surgical intervention
12-week Visual Analog Scale (VAS) pain score
Time frame: At 12 weeks from timing of surgical intervention
6-week absolute knee flexion
Time frame: At 6 weeks from timing of surgical intervention
Transfusion rate
Time frame: From enrollment to end of treatment at 12 weeks from timing of surgical intervention
Blood product units transfused
Time frame: From enrollment to end of treatment at 12 weeks from timing of surgical intervention
Incidence of Symptomatic DVT
Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention
Incidence of Symptomatic PE
Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention
Incidence of Acute Coronary Sndrome
Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention
Incidence of Cerebrovascular Accident
Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention
Rate of Readmission
Time frame: From enrollment to end of treatment at 12 weeks from timing of surgical intervention
Rate of Reoperation
Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention
All-cause Mortality Rate
Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention
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 8 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Extended oral tranexamic acid regimen in people with Osteoarthritis (OA) of the Hip and Osteoarthritis (OA) of the Knee, run by Oregon Health and Science University.
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 4 inclusion and 5 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ryland Kagan, MD (503 494-6400, kagan@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score (time frame: At 6 weeks from timing of surgical intervention). 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 8 Jul 2026.