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

Stanford University

Status and phase: Enrolling; Phase 2

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Drug: Placebos; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03552705

CDMRP-PR171647 (Other Grant/Funding Number)

46092

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Experimental group

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)

Treatment:

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

5-day course of placebo and intravenous saline during ACL reconstruction surgery

Treatment:

Drug: Placebos