Tranexamic Acid for Osteoarthritis

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Campbell Clinic

Must not be taking: Anticoagulants, Hormonal contraception

Disqualifiers: Revision TKA, DVT, Cancer, Seizures, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 10 days

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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

Fluent in oral and written English

I am willing to participate in the study.

I am having a knee replacement at Campbell Clinic, with the implant chosen by my surgeon.

Exclusion Criteria

I have had cancer before, but it was not serious or spreading.

I am currently using combined hormonal birth control.

I have a history of seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral TXA or placebo for 10 days postoperatively

10 days

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Visits at 2 weeks, 6 weeks, 12 weeks, and 1 year postoperative

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic acid

Trial Overview

The study tests the safety and effectiveness of extended postoperative use of oral TXA in patients after knee replacement surgery. Participants will receive either TXA or a placebo, and researchers aim to find the best duration for taking TXA to enhance patient outcomes.

How Is the Trial Designed?

Group I: 3-day tranexamic acid (TXA) Experimental Treatment 2 Interventions

Patients will receive three 1950 milligram (mg) doses of Oral TXA (three 650mg capsules per dose) from POD 1 to POD 3 and 7 doses of Placebo from POD 4 to POD 10.

Group II: 10-day TXA Experimental Treatment 1 Intervention

Patients will receive ten 1950mg doses of Oral TXA (three 650mg capsules per dose) from POD 1 to POD 10.

Group III: Placebo Placebo Group 1 Intervention

Patients will receive 10 doses of microcrystalline cellulose (3 capsules per dose) from postoperative day (POD) 1 to POD 10.

Tranexamic acid is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Lysteda for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma

Approved in European Union as Cyklokapron for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

Approved in Japan as Nicolda for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

Who Is Running the Clinical Trial?

Campbell Clinic

Lead Sponsor

Trials

15

Recruited

2,100+

Published Research Related to This Trial

In a study of 60 patients undergoing bilateral total knee arthroplasty, intravenous tranexamic acid (TXA) significantly reduced total blood loss and the need for blood transfusions compared to the control group, indicating its efficacy in managing perioperative blood loss.

The use of TXA did not increase the risk of deep vein thrombosis or other thromboembolic events, suggesting it is a safe option for patients undergoing knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A PROSPECTIVE RANDOMIZED SELF-CONTROLLED STUDY ON EFFECT OF TRANEXAMIC ACID IN REDUCING BLOOD LOSS IN TOTAL KNEE ARTHROPLASTY]. Huang, Z., Zhang, W., Li, W., et al.[2018]

A high initial dose of 60 mg/kg intravenous tranexamic acid (IV-TXA) significantly reduced peri-operative blood loss and transfusion rates in 132 patients undergoing total knee arthroplasty compared to a lower dose of 20 mg/kg.

Patients receiving the higher dose also experienced lower levels of inflammatory markers and pain in the days following surgery, while maintaining similar coagulation parameters and complication rates as those on the lower dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The antifibrinolytic and anti-inflammatory effects of a high initial-dose tranexamic acid in total knee arthroplasty: a randomized controlled trial. Lei, YT., Xie, JW., Huang, Q., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12447970/

Study on the Effects of Tranexamic Acid on Perioperative ...

At 2-year follow-up, TXA group showed significantly better joint function and QoL (P<0.05). Postoperative satisfaction correlated with ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12170310/

Efficacy and safety of tranexamic acid in reducing hidden ...

The study found that TXA significantly reduced total blood loss by 37.4%, with a notable decrease in hidden blood loss (p < 0.05). The TXA group ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2211383524001266

The emerging role of tranexamic acid and its principal ...

Collectively, the current evidence from animal experiments suggests beneficial effects of TXA on osteoporosis and osteoarthritis, while the underlying ...

4.

josr-online.biomedcentral.com

josr-online.biomedcentral.com/articles/10.1186/s13018-017-0660-6

The efficacy of tranexamic acid using oral administration in ...

The primary outcomes were Hb drop and blood loss. The secondary outcomes consisted of the transfusion rate, length of hospital stay, and ...

5.

link.springer.com

link.springer.com/article/10.1007/s10787-025-01679-0

Anti-inflammatory effect of multi-dose tranexamic acid in ...

Our results indicate that multi-dose TXA effectively reduces postoperative inflammatory responses in patients undergoing hip and knee arthroplasty.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10184364/

The efficacy and safety of tranexamic acid in rheumatoid ...

TXA could effectively reduce blood loss, decrease transfusion risk, shorten ambulation time and length of stay following SBTKA in patients with RA.

7.

bmcmusculoskeletdisord.biomedcentral.com

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

A comparison of efficacy and safety of oral versus intravenous ...

This meta-analysis provided updated evidence that suggests oral and intravenous TXA have similar efficacy and safety. However, oral tranexamic ...

8.

sciencedirect.com

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

Extended Postoperative Oral Tranexamic Acid in Total ...

The extended use of oral TXA in the postoperative period may safely result in improved motion, pain, and functional scores for TKA patients.

9.

eor.bioscientifica.com

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

Evidence on oral tranexamic acid versus intravenous ...

Based on the available evidence, no significant differences were observed between oral and intravenous TXA in patients undergoing TKA regarding ...