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

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Reconstruction
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Placebos

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christine L Hoang, BS; Phone Number: 650-721-7612; Email: c1hoang@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Christine Hoang; Phone Number: 650-721-7612; Email: c1hoang@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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)
Placebo Comparator: Placebo; 5-day course of placebo and intravenous saline during ACL reconstruction surgery	Drug: Placebos; 5-day course of oral placebo and intravenous saline during ACL reconstruction surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Synovial fluid IL-1	To determine whether TXA administered acutely after ACL injury reduces synovial fluid markers of inflammation and cartilage degradation	Day 5
Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)	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.	6 months post-ACLR

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative MRI (qMRI)	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	6 months post-ACLR
Quantitative MRI	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	2 years post-ACLR
Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)	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.	2 years post-ACLR

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Constance Chu, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Estimated): January 14, 2027
• Study Completion (Estimated): January 14, 2027

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Joint Diseases; Arthritis; Inflammation; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: 46092; CDMRP-PR171647 (Other Grant/Funding Number: DoD)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No