Tranexamic Acid for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness and safety of tranexamic acid (TXA) when taken orally after knee replacement surgery. The goal is to determine if different durations of TXA use after surgery improve recovery and reduce complications such as blood loss. Participants will be divided into groups to receive TXA for 10 days, TXA for 3 days, or a placebo (a harmless pill resembling the real treatment). This trial suits individuals undergoing their first knee replacement surgery who are comfortable with English. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using anticoagulants (except for 81mg aspirin) or combination hormonal contraception.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study showed that tranexamic acid (TXA) significantly reduced total blood loss by 37.4% and lowered the need for blood transfusions. Importantly, TXA did not increase the risk of blood clots, even in high-risk patients. Another study found both oral and intravenous TXA to be safe and effective. Oral TXA has been safely used after surgery to aid movement, pain relief, and overall function in patients with total knee replacements. These findings suggest that TXA is well-tolerated and safe for use in people.12345
Why are researchers excited about this trial's treatments?
Unlike the standard treatments for osteoarthritis, which often include medications like NSAIDs or corticosteroids, tranexamic acid (TXA) offers a unique approach. Researchers are excited about TXA because it is traditionally used to reduce bleeding by stabilizing blood clots, and they are exploring its potential to reduce inflammation and pain in osteoarthritis, possibly offering symptom relief with a new mechanism. The trial explores both a short-term (3-day) and a longer-term (10-day) dosing regimen, providing insights into how TXA might be optimized for managing osteoarthritis symptoms in different ways. This could represent a significant shift in osteoarthritis treatment, offering a new option for patients who may not respond well to current therapies.
What evidence suggests that this trial's treatments could be effective for osteoarthritis?
This trial will evaluate the effectiveness of tranexamic acid (TXA) in improving outcomes for osteoarthritis-related joint surgeries. Participants will be assigned to different treatment arms, including a 10-day TXA regimen, a 3-day TXA regimen, or a placebo. Studies have shown that TXA significantly reduces blood loss; one study demonstrated a 37.4% decrease in total blood loss. Reducing blood loss is important because it can make surgery safer and aid faster recovery. Research also indicates that TXA reduces inflammation after surgery, leading to less pain and swelling. Additionally, those who received TXA reported better joint function and quality of life two years post-surgery. These findings suggest TXA can be a helpful treatment for improving recovery after joint procedures.16789
Who Is on the Research Team?
Christopher Holland, MD, MS
Principal Investigator
Campbell Clinic
Are You a Good Fit for This Trial?
This trial is for patients with osteoarthritis who have undergone total knee arthroplasty. It's designed to see if taking oral Tranexamic acid (TXA) after surgery can help reduce blood loss and improve recovery. Patients must meet certain health criteria to join, but specific inclusion and exclusion details are not provided here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral TXA or placebo for 10 days postoperatively
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tranexamic acid
Tranexamic acid is already approved in United States, European Union, Japan for the following indications:
- Heavy Menstrual Bleeding
- Menstrual Disorders
- Bleeding Disorder
- Factor IX Deficiency
- Hemophilia A
- Melasma
- Heavy Menstrual Bleeding
- Menstrual Disorders
- Bleeding Disorder
- Factor IX Deficiency
- Hemophilia A
- Melasma
- Postpartum hemorrhage
- Heavy Menstrual Bleeding
- Menstrual Disorders
- Bleeding Disorder
- Factor IX Deficiency
- Hemophilia A
- Melasma
- Postpartum hemorrhage
Find a Clinic Near You
Who Is Running the Clinical Trial?
Campbell Clinic
Lead Sponsor