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

Anterior Cruciate Ligament Reconstruction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03552705
• Other study ID #: 46092
• Secondary ID: CDMRP-PR171647
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2019
• Est. completion date: January 14, 2025

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: Christine L Hoang, BS
• Phone: 650-721-7612
• Email: c1hoang[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 14, 2025
• Est. primary completion date: January 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction
• Arthritis
• Inflammation

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Synovial fluid IL-1	To determine whether TXA administered acutely after ACL injury reduces synovial fluid markers of inflammation and cartilage degradation	Day 5
Primary	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	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
Secondary	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
Secondary	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