Extended Oral Tranexamic Acid After Anterior Cruciate Ligament Reconstruction

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.

Conditions

• ACL Injury
• ACL Tears
• ACL Surgery

Interventions

DRUG

Tranexamic Acid (TXA)

Oral tranexamic acid (TXA) is administered at a dose of 1.95 grams per day, divided into three 650 mg capsules taken once daily, starting on postoperative day (POD) 1 through POD 10 (10 total doses; 30 capsules) to the treatment group.

DRUG

Placebo

Participants in this arm will receive oral placebo capsules (microcrystalline cellulose), 3 capsules daily from postoperative day (POD) 1 to POD 10, for a total of 10 doses (30 capsules).

Sponsors & Collaborators

• Duke University

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Endeavor Health

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Campbell Clinic

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2028-12-31

Completion

2029-12-31

FDA Drug

Yes

Countries

• United States

Study Locations