Extended Oral Tranexamic Acid After Anterior Cruciate Ligament Reconstruction

This is a prospective, multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy of oral tranexamic acid (TXA) in improving postoperative outcomes following anterior cruciate ligament reconstruction (ACLR) using patellar tendon autograft in adolescent and young adult patients. A total of 100 patients, aged 14 to 22 years and undergoing eligible ACLR, will be enrolled across multiple participating sites. Eligible participants will be randomized 1:1 to receive either oral TXA (1.95 g per day, divided into three 650 mg capsules) or placebo (microcrystalline cellulose) once daily from postoperative day 1 to 10, in addition to standard intraoperative care. All participants will receive 1 g IV TXA prior to incision and 1 g IV TXA at closure, per standard surgical protocol. The primary outcome is improvement in postoperative pain, as measured by the Visual Analog Scale (VAS). Secondary outcomes are knee range of motion, quadriceps strength, isokinetic strength, time to straight leg raise, time to return to sport, International Knee Documentation Committee score, Lyshom score, and morphine milligram equivalents. Participants will be followed through routine postoperative visits at the participating institutions out to one year with a phone call for patient reported outcomes at 2 years.

NCT Number	NCT07115056
Lead Sponsor	Campbell Clinic Collaborators: Duke University, University of Pittsburgh, Endeavor Health, University of Cincinnati, Washington University School of Medicine
Conditions	ACL Injury, ACL Tears, ACL Surgery
Start Date	2026-04-01
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-03