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Antifibrinolytic agent

Tranexamic Acid for Post-ACL Injury Arthritis

Phase 2

Recruiting

Led By Constance Chu, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post-aclr

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial will test whether Tranexamic Acid can prevent or delay arthritis after an ACL injury.

Who is the study for?

This trial is for young adults aged 18-30 who have recently (within 4 days) injured their ACL and have joint swelling. It's not for those with a history of knee issues, arthritis, gout, recent cortisone injections to the knee, or thromboembolic disease. People using certain contraceptives or chronic NSAIDs are also excluded.

What is being tested?

The study tests if Tranexamic Acid (TXA), which reduces bleeding after an ACL injury and surgery, can lessen inflammation and improve joint health to prevent or delay arthritis onset compared to a placebo.

What are the potential side effects?

Tranexamic Acid may cause side effects such as nausea, diarrhea, muscle cramps or spasms. Rarely it might lead to blood clots; however specific side effects in this trial will be monitored closely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post-aclr

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post-aclr

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-aclr for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Synovial fluid IL-1

Secondary study objectives

Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)

Quantitative MRI

Quantitative MRI (qMRI)

Side effects data

From 2015 Phase 4 trial • 29 Patients • NCT02063035

Postoperative wound infection

Postoperative wound infection after release from hospital

Myocardial infaction

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Tranexamic Acid

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Tranexamic AcidExperimental Treatment1 Intervention

5-day course of standard adult oral tranexamic acid dosage of 1300 mg taken 3 times a day (3900 mg/day) and intravenous tranexamic acid during ACL reconstruction surgery (1 gram of iv TXA just prior to incision and 1 gram of iv TXA just prior to wound closure)

Group II: PlaceboPlacebo Group1 Intervention

5-day course of placebo and intravenous saline during ACL reconstruction surgery

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic acid

FDA approved

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