Back to resultsThe Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients
Primary Purpose
Anterior Cruciate Ligament Reconstruction
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Reconstruction
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
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tranexamic Acid
Placebo
Arm Description
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)
5-day course of placebo and intravenous saline during ACL reconstruction surgery
Outcomes
Primary Outcome Measures
Synovial fluid IL-1
To determine whether TXA administered acutely after ACL injury reduces synovial fluid markers of inflammation and cartilage degradation
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.
Secondary Outcome Measures
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
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
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.
Full Information
NCT ID
NCT03552705
First Posted
May 29, 2018
Last Updated
September 19, 2023
Sponsor
Stanford University
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT03552705
Brief Title
The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 14, 2024 (Anticipated)
Study Completion Date
January 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
United States Department of Defense
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blinded RCT
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic Acid
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5-day course of placebo and intravenous saline during ACL reconstruction surgery
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
5-day course of oral placebo and intravenous saline during ACL reconstruction surgery
Primary Outcome Measure Information:
Title
Synovial fluid IL-1
Description
To determine whether TXA administered acutely after ACL injury reduces synovial fluid markers of inflammation and cartilage degradation
Time Frame
Day 5
Title
Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
6 months post-ACLR
Secondary Outcome Measure Information:
Title
Quantitative MRI (qMRI)
Description
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
Time Frame
6 months post-ACLR
Title
Quantitative MRI
Description
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
Time Frame
2 years post-ACLR
Title
Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
2 years post-ACLR
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine L Hoang, BS
Phone
650-721-7612
Email
c1hoang@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance Chu, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Hoang
Phone
650-721-7612
Email
c1hoang@stanford.edu
12. IPD Sharing Statement
Learn more about this trial
The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients
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