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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT03552705
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anterior Cruciate Ligament Reconstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Tranexamic Acid — DRUG
    5-day course of oral 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)
  • Placebos — DRUG
    5-day course of oral placebo and intravenous saline during ACL reconstruction surgery

Study Details

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.

Key Dates

Start date
Aug 1, 2019
Status verified
Jan 2026
Primary completion
Jan 14, 2027
Completion
Jan 14, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tranexamic Acid
    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)
  • Placebo Comparator: Placebo
    5-day course of placebo and intravenous saline during ACL reconstruction surgery

Primary Outcome Measure

Synovial fluid IL-1 [ Time Frame: Day 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Christine Hoang
[email protected]
650-721-7612

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By research site
Stanford University· Stanford, CA

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