RecruitingPhase 2

The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients

United States50 participantsStarted 2019-08-01

Plain-language summary

Patients who tear their ACL are at high risk for developing arthritis (post-traumatic osteoarthritis-PTOA) just 10 years later. Joint bleeding and inflammation contribute to deterioration of joint health. This study will determine whether treatment with Tranexamic Acid (TXA), an FDA approved medication that reduces bleeding right after ACL injury and reconstructive surgery reduces inflammation and improves joint health as a new strategy to prevent or delay the onset of PTOA.

Who can participate

Age range18 Years – 30 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age 18-30 years * within 4 days of unilateral ACL injury * presence of effusion/hemarthrosis. Exclusion Criteria: * inflammatory arthritis, radiographic osteoarthritis (K-L Grade 2 or higher), gout/ pseudogout * systemic or acute illness requiring medications * concomitant knee injury aside from meniscus tear and MCL tear not requiring surgery * prior surgery to either knee * prior injury to either knee requiring crutches * history of thromboembolic disease * current use of combination hormonal contraception * chronic NSAID use * cortisone injection to either knee within the prior 3 months * not indicated for or unable to undergo ACLR within 3 months of injury

What they're measuring

Synovial fluid IL-1

Timeframe: Day 5

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

Timeframe: 6 months post-ACLR

Trial details

NCT IDNCT03552705

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-14

Contact for this trial

Christine L Hoang, BS

650-721-7612 c1hoang@stanford.edu