Recruiting
Phase 2

Tranexamic Acid

Sponsor:

Stanford University

Code:

NCT03552705

Conditions

Anterior Cruciate Ligament Reconstruction

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Interventions

Tranexamic Acid

Placebos

Study Details

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Study ID

NCT03552705

Start date

Aug 1, 2019

Status verified date

Jan, 2026

Completion date

Jan 14, 2027

Anticipated

Primary completion date

Jan 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Tranexamic 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)

Placebos

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

Primary outcome measure

  • Synovial fluid IL-1 [ Time Frame: Day 5 ]
  • Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 6 months post-ACLR ]

Central Contacts and Locations

Central contacts

Christine L Hoang, BS

650-721-7612c1hoang@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Christine Hoang

650-721-7612c1hoang@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Feb 27, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-02-27.