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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 30 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03552705
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Stanford University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Constance Chu, MD
Principal Investigator Affiliation Stanford University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, U.S. Fed
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Anterior Cruciate Ligament Reconstruction
Arms & Interventions

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

Drug: - 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)

Drug: - Placebos

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University, Stanford, California

Status

Recruiting

Address

Stanford University

Stanford, California, 94305

Site Contact

Christine Hoang

[email protected]

650-721-7612

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