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NOT YET RECRUITING
NCT07880743
PHASE3

Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction

Sponsor: Dave Bernholt

View on ClinicalTrials.gov

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

DRUG

Tranexamic Acid

Compounded 650 mg oral capsules (USP-grade TXA, microcrystalline cellulose filler), 1.95 g once daily POD 0-7.

DRUG

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