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

101 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Tranexamic Acid for joint replacement surgery?

Research shows that oral Tranexamic Acid can effectively reduce blood loss in patients undergoing total knee and hip replacement surgeries. This drug is easy to administer and helps minimize bleeding during and after surgery, making it a useful option for these procedures. ^{1 2 3 4 5}

How does oral tranexamic acid differ from other treatments for joint replacement surgery?

Oral tranexamic acid is unique because it is taken by mouth, making it easier to administer compared to intravenous forms, and it is less expensive. It effectively reduces blood loss during joint replacement surgeries, similar to intravenous forms, but without the need for needles or special equipment. ^{4 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Joshua Bingham

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Oral tranexamic acid can reduce blood loss after total knee and hip arthroplasty: A meta-analysis. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Blood-conserving efficacy of multiple doses of oral tranexamic acid associated with an enhanced-recovery programme in primary total knee arthroplasty: a randomized controlled trial. [2018]

3. Brazil pubmed.ncbi.nlm.nih.gov

Evaluation of the use of tranexamic acid in total knee arthroplasty. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of oral Tranexamic acid administration on blood loss after knee artroplasty: a randomized clinical trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The efficacy and safety of multiple doses of oral tranexamic acid on blood loss, inflammatory and fibrinolysis response following total knee arthroplasty: A randomized controlled trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of Oral and Intravenous Tranexamic Acid for Prevention of Perioperative Blood Loss in Total Knee and Total Hip Arthroplasty. [2019]

8. England pubmed.ncbi.nlm.nih.gov

The optimal regimen of oral tranexamic acid administration for primary total knee/hip replacement: a meta-analysis and narrative review of a randomized controlled trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Oral and Intravenous Tranexamic Acid Are Equivalent at Reducing Blood Loss Following Total Hip Arthroplasty: A Randomized Controlled Trial. [2022]