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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2026-01-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Anterior Cruciate Ligament Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double blinded RCT

Study Groups

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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)

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

Placebos

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No