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NCT Number: NCT03552705

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

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.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Christine Hoang

CONTACT

[email protected]

650-721-7612

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Synovial fluid IL-1

    Time frame: Day 5

    To determine whether TXA administered acutely after ACL injury reduces synovial fluid markers of inflammation and cartilage degradation

  2. Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 6 months post-ACLR

    To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves PRO (KOOS Quality of Life) at 6 months after ACLR. The Knee injury and Osteoarthritis Outcome Score (KOOS) assesses a patient's opinion about their knee and associated problems. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated.

Secondary outcomes

  1. Quantitative MRI (qMRI)

    Time frame: 6 months post-ACLR

    To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves cartilage subsurface matrix structure assessed by qMRI UTE-T2* at 6 months after ACLR

  2. Quantitative MRI

    Time frame: 2 years post-ACLR

    To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves cartilage subsurface matrix structure assessed by qMRI UTE-T2* at 2 years after ACLR

  3. Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 2 years post-ACLR

    To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves PRO (KOOS Quality of Life) at 2 years after ACLR. The Knee injury and Osteoarthritis Outcome Score (KOOS) assesses a patient's opinion about their knee and associated problems. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine L Hoang, BS

CONTACT

[email protected]

650-721-7612

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2018
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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