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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552705
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Constance R. Chu, MD, Stanford University

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Drug: Tranexamic Acid Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double blinded RCT
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


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




Primary Outcome Measures :
  1. Synovial fluid IL-1 [ Time Frame: Day 5 ]
    To determine whether TXA administered acutely after ACL injury reduces synovial fluid markers of inflammation and cartilage degradation

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

  2. Quantitative MRI [ Time Frame: 2 years post-ACLR ]
    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

  3. Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 2 years post-ACLR ]
    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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552705


Contacts
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Contact: Jennifer Hledik, PhD 650-721-7612 jerhart@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Christine Hoang    650-721-7612    c1hoang@stanford.edu   
Contact: Brittney Deadwiler    650-721-7612    brittcd@stanford.edu   
Sponsors and Collaborators
Stanford University
United States Department of Defense
Investigators
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Principal Investigator: Constance Chu, MD Stanford University

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Responsible Party: Constance R. Chu, MD, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03552705    
Other Study ID Numbers: 46092
CDMRP-PR171647 ( Other Grant/Funding Number: DoD )
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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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
Additional relevant MeSH terms:
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Arthritis
Inflammation
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants