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NCT03552705 | RECRUITING | Anterior Cruciate Ligament Reconstruction


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

Stanford University

Information provided by (Responsible Party):

Constance R. Chu, MD

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

Anterior Cruciate Ligament Reconstruction

Intervention/treatment

Tranexamic Acid

Placebos

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : QUADRUPLE
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 : 2019-08-01
Estimated Primary Completion Date : 2025-01-14
Estimated Study Completion Date : 2025-01-14

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 30 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT03552705


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Locations


RECRUITING

United States, California

Stanford University

Stanford, California, United States, 94305

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