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Anti-fibrinolytic agent

Tranexamic Acid for Osteoarthritis

Phase 3

Waitlist Available

Led By Christopher Holland, MD, MS

Research Sponsored by Campbell Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age and older

Be older than 18 years old

Must not have

Patients who are using combination hormonal contraception

History of seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

Awards & highlights

Pivotal Trial

Summary

"This trial aims to study the effectiveness and safety of giving oral tranexamic acid (TXA) after joint replacement surgery. Previous studies have shown that TXA can reduce blood loss and improve recovery after

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While detailed side effects are not listed, previous studies suggest that TXA does not increase the risk of venous thromboembolism (VTE). However, as with any medication, there may be risks which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using combined hormonal birth control.

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I have a history of seizures.

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I am scheduled for or have had a revision of my knee replacement.

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I have had a deep vein thrombosis in the past.

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I have developed colorblindness as an adult.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Forgotten Joint Score - Knee

Range of Motion

Secondary study objectives

Adverse Event

Ambulatory aid

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 3-day tranexamic acid (TXA)Experimental Treatment2 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 TXAExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic acid

2018

Completed Phase 4

~42540