NCT07115056 — drugset

Summary

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.

Timeline

Start: 2026-04-01
Primary completion: 2028-12-31
Completion: 2029-12-31

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tranexamic Acid	Small molecule	1 g	Oral
Subject	Tranexamic Acid	Small molecule	1.95 g	Oral

Indications

No indication recorded.

Extended Oral Tranexamic Acid After Anterior Cruciate Ligament Reconstruction

Summary

Timeline

Publications

Drugs

Indications