ArthroplastyPhase 4NCT06832878
Postoperative Oral Tranexamic Acid in Patients Undergoing Primary Total Joint Arthroplasty
A Phase 4 study testing Oral Tranexamic Acid in people with Arthroplasty, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of an extended oral Tranexamic Acid regimen on patient reported outcome scores, time to independent ambulation, postoperative range of motion, swelling, change in hemoglobin levels, 90-day complications, readmission and reoperation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty
- What is being tested?
- Oral Tranexamic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to Jun 2027
- 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
- Adults aged > 18 years (All women of childbearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
- Written informed consent
- Patients undergoing primary THA diagnosis of end-stage osteoarthritis
- Patients receiving spinal anesthesia
- Patients being discharged on postoperative day 1
Who cannot join
- Patients with a TXA allergy
- Patients undergoing revision procedures
- Patients undergoing primary THA for a diagnosis other than end-stage osteoarthritis
- Patients receiving general anesthesia
- Patients being discharged on the same day of surgery
- Cancer patients
Show all 11Show fewer
- Patients with a history of prior VTE event
- Patients on preoperative anticoagulants other than ASA
- Pregnant patients (All women of child bearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
- Female patients who are on hormonal contraception
- Patients with history of retinal vein or artery occlusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Saad Tarabichi, MD, 267-694-5292, tarabichi.saad@mayo.edu
Joshua Scott Bingham
About this study
The purpose of this study is to evaluate the impact of an extended oral Tranexamic Acid regimen on patient reported outcome scores, time to independent ambulation, postoperative range of motion, swelling, change in hemoglobin levels, 90-day complications, readmission and reoperation.
- Conditions
- Arthroplasty
- Being tested
- Oral Tranexamic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Tranexamic AcidDrug
Subjects will receive a 1.95 g dose of oral TXA at the following timepoints: (1) following ambulation, (2) postoperative day 1, (3) postoperative day 2, and (4) postoperative day 3
| Study group | Role | What they receive |
|---|---|---|
| Oral tranexamic acid | Experimental | Not described Receives: Drug: Oral Tranexamic Acid |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score
The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.
Measured: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR)
The Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR) is a questionnaire designed to measure outcomes for patients with hip replacements. Results are scored 0-11. 0 = total hip disability, 100 = perfect hip health.
Measured: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
Secondary outcomes (5)
Hemoglobin
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin
Measured: Baseline, prior to discharge, day 3 postoperatively
Harris Hip Score (HHS)
The Harris Hip Score (HHS) is a tool used to assess hip function and the results of hip treatments, such as hip replacements. It's a 100-point scale that measures four areas: pain, function, deformity, and range of motion. A higher score indicates less dysfunction and better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, and 90-100 is excellent.
Measured: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
Short Form Health Survey (SF-12)
The 12-Item Short Form Health Survey (SF-12) is a questionnaire which consists of 12 questions covering physical and mental health domains. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Measured: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
Time to Independent Ambulation
Duration of time post-operation until the subject can walk without any support or assistance, reported in days
Measured: 12 weeks
Oxford Hip Score
The Oxford Hip Score (OHS) is a standard patient-reported outcome (PRO) measure, or PROM, developed to assess function and pain in patients undergoing total hip replacement (THR) surgery, particularly in the context of clinical trials. The OHS has also been used for the assessment of patient outcomes, including physical therapy, and use of joint supplements (disease specific and general health measure are two other outcome measures).
Measured: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua S. Bingham, Mayo Clinic
- Investigators
- Joshua Bingham, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832878
- Sponsor's protocol ID
- 24-008865
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2025
- Last updated
- 10 Aug 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Oral Tranexamic Acid in Patients Undergoing Primary Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT06832878
- Acronym / sponsor ID
- 24-008865
- Conditions
- Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Feb 2025 (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 purpose of this study is to evaluate the impact of an extended oral Tranexamic Acid regimen on patient reported outcome scores, time to independent ambulation, postoperative range of motion, swelling, change in hemoglobin levels, 90-day complications, readmission and reoperation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral tranexamic acid | Experimental | Drug: Oral Tranexamic Acid |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged > 18 years (All women of childbearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
- Written informed consent
- Patients undergoing primary THA diagnosis of end-stage osteoarthritis
- Patients receiving spinal anesthesia
- Patients being discharged on postoperative day 1
Key exclusion criteria (11 listed)
- Patients with a TXA allergy
- Patients undergoing revision procedures
- Patients undergoing primary THA for a diagnosis other than end-stage osteoarthritis
- Patients receiving general anesthesia
- Patients being discharged on the same day of surgery
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 |
|---|---|---|
| Oral Tranexamic AcidSubjects will receive a 1.95 g dose of oral TXA at the following timepoints: (1) following ambulation, (2) postoperative day 1, (3) postoperative day 2, and (4) postoperative day 3 | Drug | Oral tranexamic acid |
Primary outcome
Visual Analog Score
Time frame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.
Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR)
Time frame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
The Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR) is a questionnaire designed to measure outcomes for patients with hip replacements. Results are scored 0-11. 0 = total hip disability, 100 = perfect hip health.
5 secondary outcomes
Hemoglobin
Time frame: Baseline, prior to discharge, day 3 postoperatively
Harris Hip Score (HHS)
Time frame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
Short Form Health Survey (SF-12)
Time frame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
Time to Independent Ambulation
Time frame: 12 weeks
Oxford Hip Score
Time frame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
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 10 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Joshua Bingham principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Tranexamic Acid in people with Arthroplasty, run by Mayo Clinic 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 10 Aug 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Score (time frame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks). The study lists 2 primary outcomes in all. 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 10 Aug 2026.