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RecruitingPhase 2NCT03552705

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

Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA):The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients

Sponsor

Stanford University

Enrollment

50 participants

Start Date

Aug 1, 2019

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 30 Years

Inclusion Criteria3

  • age 18-30 years
  • within 4 days of unilateral ACL injury
  • presence of effusion/hemarthrosis.

Exclusion Criteria10

  • 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

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Interventions

DRUGTranexamic Acid

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)

DRUGPlacebos

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

Locations(1)

Stanford University

Stanford, California, United States

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NCT03552705