The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients
Recruiting · NCT03552705 · Interventional (participants receive a specific treatment) · Lead sponsor: Stanford University
View the official record on ClinicalTrials.gov →Interventions studied
PlacebosTranexamic Acid
What this trial is about
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 take part
Age range
18 Years to 30 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Stanford University - Stanford, California, United States