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Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Sponsor: Dave Bernholt
Summary
The goal of this clinical trial is to learn whether taking oral tranexamic acid (TXA) for one week after anterior cruciate ligament (ACL) reconstruction improves recovery in adolescents and young adults aged 14 to 25 years. All participants receive standard intravenous TXA during surgery. The main questions it aims to answer are: * Does oral TXA lower knee pain at 2 weeks after surgery? * Does oral TXA reduce the amount of opioid pain medicine used in the first 2 weeks? * Does oral TXA improve knee range of motion at 2 weeks? Researchers will compare oral TXA to a placebo (a look-alike capsule with no active drug) to see if oral TXA improves pain, opioid use, motion, strength, knee function, and return to sport. Participants will: * Take 3 capsules (oral TXA or placebo) once a day for the first 8 days after surgery (day of surgery through day 7) * Keep a home diary for 2 weeks recording pain scores, opioid pills taken and any side effects * Return for study visits at 2 weeks, 6 weeks, 12 weeks, 6 months, 9 months and 1 year for pain, motion, strength and function testing * Complete a survey at 2 years
Official title: Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction: A Multicenter Randomized Controlled Trial (SM25091)
Key Details
Gender
All
Age Range
14 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-11
Completion Date
2028-12
Last Updated
2026-10-19
Healthy Volunteers
No
Interventions
Tranexamic Acid
Compounded 650 mg oral capsules (USP-grade TXA, microcrystalline cellulose filler), 1.95 g once daily POD 0-7.
Placebo
Matching capsules containing microcrystalline cellulose NF, three once daily POD 0-7.
Locations (6)
Endeavor Health/NorthShore
Skokie, Illinois, United States
Washington University School of Medicine
St Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
University of Cincinnati / UC Health Orthopaedics & Sports Medicine
Cincinnati, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Campbell Clinic
Germantown, Tennessee, United States