Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction

This multicenter, investigator-initiated, randomized, double-blind, placebo-controlled trial is conducted under IND 177715 at the University of Cincinnati (coordinating center) and five U.S. academic sites. One hundred participants undergoing isolated primary ACL reconstruction with bone-patellar tendon-bone autograft will be randomized 1:1 at the conclusion of surgery to oral TXA 1.95 g (three 650 mg capsules) once daily or matching microcrystalline cellulose placebo on postoperative days 0 through 7. All participants receive 1 g IV TXA before incision and 1 g IV TXA at closure, plus a standardized postoperative medication regimen. Intraoperative IV TXA is established in ACL reconstruction for reducing pain and hemarthrosis. A pilot randomized trial in total knee arthroplasty found improved motion and outcome scores at 6 weeks with extended oral TXA. This trial tests whether a similar benefit applies to a younger, active ACL reconstruction population. Sample size is based on detecting a 2.0-point difference in VAS pain (SD 3.0), requiring 35 per group; 50 per group allows for about 20% loss to follow-up. Analysis is intention-to-treat.