Oral Tranexamic Acid for Joint Replacement Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants, Hormonal contraception

Disqualifiers: Cancer, VTE, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of oral Tranexamic Acid, a medication that reduces bleeding, for individuals undergoing joint replacement surgery. Researchers aim to determine if this medication can enhance recovery, such as enabling independent walking sooner, reducing swelling, and lowering the risk of complications. The trial includes two groups: one taking the medication and one not taking it. Candidates may be suitable if they are undergoing their first hip replacement surgery due to severe arthritis and are expected to leave the hospital the day after surgery. As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment benefits more patients, offering participants a chance to contribute to broader medical knowledge.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes patients on certain preoperative anticoagulants (blood thinners) other than aspirin and those on hormonal contraception. It's best to discuss your specific medications with the trial team.

What is the safety track record for Tranexamic Acid?

Research has shown that taking tranexamic acid orally is generally safe for surgeries like joint replacements. Studies have found it effectively reduces blood loss during these operations. It matches the effectiveness of the intravenous form, commonly used in similar surgeries. As a result, oral tranexamic acid helps maintain better blood levels, reducing the need for blood transfusions.

Regarding safety, available data indicates that oral tranexamic acid does not increase the risk of complications compared to other methods. It has been widely used in surgeries, with patients reporting good results and no major side effects. The FDA has already approved the medication for other uses, suggesting its safety.

In summary, based on current research and past use in similar surgeries, oral tranexamic acid is considered safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about oral tranexamic acid for joint replacement surgery because it offers a potentially more convenient option compared to the standard intravenous administration. This treatment works by helping to reduce blood loss during surgery, which is crucial for patient recovery. Unlike other treatments that require injections, oral tranexamic acid can be taken in pill form, making it easier for patients to manage. This new delivery method might improve patient comfort and compliance while maintaining effectiveness in preventing blood loss.

What is the effectiveness track record for Tranexamic Acid in joint replacement surgery?

Research has shown that oral tranexamic acid, which participants in this trial may receive, effectively reduces blood loss during joint replacement surgeries, such as total knee and hip replacements. Studies have found that it significantly decreases the need for blood transfusions, allowing patients to lose less blood and recover faster. A review of multiple studies found that oral tranexamic acid helps maintain stable hemoglobin levels (the protein in red blood cells) after surgery. This treatment is also considered safe, making it a reliable option for managing blood loss in these procedures. ^{6 7 8 9 10}

Who Is on the Research Team?

Joshua Bingham

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients scheduled for primary total joint replacement surgery. Specific eligibility details are not provided, but typically participants should be in good health aside from the joint issue and able to follow postoperative instructions.

Inclusion Criteria

Written informed consent

I am having a hip replacement due to severe arthritis.

I am receiving spinal anesthesia.

Exclusion Criteria

I am scheduled for a corrective surgical procedure.

I am taking blood thinners other than aspirin before surgery.

Patients with a TXA allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an extended oral Tranexamic Acid regimen postoperatively

12 weeks

Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of hemoglobin levels and hip scores

12 weeks

Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The study tests if taking oral Tranexamic Acid after joint replacement surgery helps with recovery. It looks at patient satisfaction, how soon they can walk on their own, range of motion, swelling, blood levels changes, and any complications within 90 days.

How Is the Trial Designed?

Group I: Oral tranexamic acid Experimental Treatment 1 Intervention

Group II: Control Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6393150/

Efficacy and safety of oral tranexamic acid in total knee ... Our meta-analysis suggested that the administration of oral TXA provided significantly better results with respect to Hb drop, Hct drop, and drain output ...

2. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(24)00193-1/fulltext

Extended Postoperative Oral Tranexamic Acid in Total ... We aimed to investigate the safety and clinical efficacy of extended postoperative oral TXA use in TKA performed in an American, free-standing ambulatory ...

3. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(22)00635-3/fulltext

Effectiveness of oral versus intravenous tranexamic acid in ... Tranexamic acid (TXA) reduces rates of blood transfusion for total hip arthroplasty (THA) and total knee arthroplasty (TKA).

4. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/33875-tranexamic-acid-in-total-knee-replacement-and-total-hip-replacement-a-single-center-retrospective-observational-study

Tranexamic acid in total knee replacement and total hip ... We conclude that two doses of 1g TXA administered [intravenously (IV)] before incision and during skin suturing reduce the need for blood transfusion in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03690037

Investigating the Effect of Intravenous and Oral Tranexamic ... This trial aims to find out how well tranexamic acid works to reduce blood loss after the operation in a large group of patients having a hip or knee ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38889241/

Efficacy and Safety of Oral Tranexamic Acid vs. Other ... Background: Total joint arthroplasty (TJA) is often associated with significant blood loss, leading to complications such as acute anemia ...

7. eor.bioscientifica.com eor.bioscientifica.com/view/journals/eor/10/10/EOR-2025-0027.xml

Evidence on oral tranexamic acid versus intravenous ... The results of our meta-analysis are consistent with previous studies. For TKA, oral TXA is as effective as intravenous TXA in terms of blood ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540324001931

Extended Postoperative Oral Tranexamic Acid in Total ... The addition of an extended oral TXA regimen improved short-term patient-reported outcomes at 2 and 6 weeks following TKA (Table 2). Patients who received oral ...

9. journals.lww.com journals.lww.com/md-journal/fulltext/2018/05040/efficacy_and_safety_of_oral_tranexamic_acid_in.26.aspx

Efficacy and safety of oral tranexamic acid in total knee... Tranexamic acid (TXA) is an antifibrinolytic drug widely used as a blood-sparing technique in total knee arthroplasty (TKA), and it is usually administrated ...

10. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-09193-8

A comparison of efficacy and safety of oral versus intravenous ... Tranexamic acid (TXA) has been extensively used in total hip and total knee arthroplasty (THA and TKA) to reduce blood loss.