The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic Acid, Placebos.
- Who it may be relevant to
- Registry conditions: Anterior Cruciate Ligament Reconstruction. Basic parameters: 18 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
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
Primary outcome measures
- 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]
Secondary outcome measures (3)
- Quantitative MRI (qMRI) [Time frame: 6 months post-ACLR]
- Quantitative MRI [Time frame: 2 years post-ACLR]
- Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS) [Time frame: 2 years post-ACLR]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT03552705 · 46092 · CDMRP-PR171647