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Antifibrinolytic agent

Tranexamic Acid for Post-ACL Injury Arthritis

Phase 2
Recruiting
Led By Constance Chu, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post-aclr
Awards & highlights

Study Summary

This trial will test whether Tranexamic Acid can prevent or delay arthritis after an ACL injury.

Who is the study for?
This trial is for young adults aged 18-30 who have recently (within 4 days) injured their ACL and have joint swelling. It's not for those with a history of knee issues, arthritis, gout, recent cortisone injections to the knee, or thromboembolic disease. People using certain contraceptives or chronic NSAIDs are also excluded.Check my eligibility
What is being tested?
The study tests if Tranexamic Acid (TXA), which reduces bleeding after an ACL injury and surgery, can lessen inflammation and improve joint health to prevent or delay arthritis onset compared to a placebo.See study design
What are the potential side effects?
Tranexamic Acid may cause side effects such as nausea, diarrhea, muscle cramps or spasms. Rarely it might lead to blood clots; however specific side effects in this trial will be monitored closely.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post-aclr
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-aclr for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Synovial fluid IL-1
Secondary outcome measures
Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)
Quantitative MRI
Quantitative MRI (qMRI)

Side effects data

From 2015 Phase 4 trial • 29 Patients • NCT02063035
8%
Postoperative wound infection
8%
Postoperative wound infection after release from hospital
8%
Myocardial infaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tranexamic Acid

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tranexamic AcidExperimental Treatment1 Intervention
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)
Group II: PlaceboPlacebo Group1 Intervention
5-day course of placebo and intravenous saline during ACL reconstruction surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
FDA approved

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,341,266 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Reconstruction
765 Patients Enrolled for Anterior Cruciate Ligament Reconstruction
United States Department of DefenseFED
863 Previous Clinical Trials
227,582 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Reconstruction
45 Patients Enrolled for Anterior Cruciate Ligament Reconstruction
Constance Chu, MDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
70 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Reconstruction
45 Patients Enrolled for Anterior Cruciate Ligament Reconstruction

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Tranexamic Acid officially sanctioned by the FDA?

"Tranexamic Acid has been evaluated in a Phase 2 trial, and was thus given an evaluation of 2 on the safety scale due to limited efficacy data."

Answered by AI

Does this investigation extend to geriatric populations?

"Applicants aged 18 to 30 are eligible for this medical trial, with 86 studies targeting paediatric patients and 625 focusing on seniors."

Answered by AI

Are there still openings available in this trial for participants?

"As per the clinicaltrials.gov listing, this research study is presently procuring participants. The initial announcement for this trial was made in August 2019 and its details were recently amended on October 23rd 2020."

Answered by AI

What therapeutic uses does Tranexamic Acid have?

"Tranexamic Acid is known to be a successful treatment for hyperfibrinolysis, as well as hemophilia, dental bleeding during extractions, and other related issues."

Answered by AI

How much participation has been achieved in this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this research trial is currently seeking participants for its study that was first posted on August 1st 2019 and most recently updated on October 23rd 2020. The goal is to enrol 50 individuals at one medical centre."

Answered by AI

Do I qualify for participation in this medical experiment?

"The research team is searching for 50 volunteers aged 18 to 30 years old with a current ACL reconstruction and effusion/hemarthrosis. Additionally, the injury must have occurred within 4 days of enrollment in this trial."

Answered by AI

What other investigations have taken place with regards to Tranexamic Acid?

"At this time, 61 studies concerning Tranexamic Acid are in operation with 26 experiments progressing to their final stage. Most of these trials occur near Kansas City, KS; however 185 other locations also offer research into Tranexamic Acid."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have ongoing knee pain and/or swelling since Meniscus surgery in 2015 and again in 2020. Looking for long term remedy.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients
Constance R. Chu, MD 2019. "The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03552705.
All > Arthritis
~6 spots leftby Jan 2025
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