NCT03552705 The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients
| NCT ID | NCT03552705 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stanford University |
| Condition | Anterior Cruciate Ligament Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2019-08-01 |
| Primary Completion | 2027-01-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2019-08-01 with a primary completion date of 2027-01-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Constance Chu, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT03552705 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 30 Years, studying Anterior Cruciate Ligament Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03552705 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03552705 currently recruiting?
Yes, NCT03552705 is actively recruiting participants. Contact the research team at c1hoang@stanford.edu for enrollment information.
Where is the NCT03552705 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT03552705 clinical trial?
NCT03552705 is sponsored by Stanford University. The principal investigator is Constance Chu, MD at Stanford University. The trial plans to enroll 50 participants.