Extended Oral Tranexamic Acid After Anterior Cruciate Ligament Reconstruction

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: ACL Injury, ACL Tears, ACL Surgery

In brief

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.

Key facts

Study ID

NCT07115056

Run by

Campbell Clinic

People needed

0

Starts

2026-04-01

Expected to finish

2029-12-31

Last updated by the study team

2026-03-03

Who can join

Age: 14 and older, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 14-22 year old individuals with ACL tear undergoing primary ACLR with patellar tendon autograft.
• Closed or closing proximal tibial and distal femoral physes on pre-operative radiographs (less than one year of growth remaining based on MRI and radiographic bone age assessment)
• Fluent in English
• Willing to participate
• Patient weight greater than or equal to 100lbs (45.4kg)

You may not qualify if…

• Revision ACLR, multi-ligamentous knee reconstruction, inclusion of lateral extra-articular tenodesis (LET) or Anterolateral Ligament (ALL) reconstruction
• Concomitant meniscal repair or chondral preservation surgery requiring postoperative limited weightbearing status (nonweightbearing or partial weightbearing)
• Have a prior history of deep vein thrombosis (DVT) or thromboembolic event
• Known allergy or hypersensitivity to TXA
• Using combination hormonal contraception

Where it is running

• Endeavor Health — Evanston, Illinois, United States
• Washington University School of Medicine in St. Louis — Chesterfield, Missouri, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Campbell Clinic — Germantown, Tennessee, United States

Full record on ClinicalTrials.gov

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