Extended Oral Tranexamic Acid After Anterior Cruciate Ligament Reconstruction

Campbell Clinic

Status and phase: Begins enrollment in 1 month; Phase 4

Conditions: ACL Surgery; ACL Tears; ACL Injury

Treatments: Drug: Tranexamic Acid (TXA); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07115056

Oral TXA After ACL-R

Details and patient eligibility

About

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.

Full description

This multi-center, prospective, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the effect of oral tranexamic acid (TXA) on postoperative outcomes following anterior cruciate ligament reconstruction (ACLR) using bone-tendon-bone (BTB) autograft in adolescent and young adult patients.

Background:

Tranexamic acid is a synthetic antifibrinolytic agent that competitively inhibits plasminogen activation, helping to reduce bleeding. IV TXA is routinely used during orthopedic procedures, including ACLR, and has been shown to reduce intraoperative blood loss. However, the benefit of extending antifibrinolytic coverage with oral TXA in the early postoperative period has not been well studied in this population. This trial aims to investigate whether a 10-day postoperative course of oral TXA improves pain and recovery outcomes following ACLR.

Study Design:

Participants will be randomized in a 1:1 ratio to receive either oral TXA or a placebo. Randomization will be conducted using computer-generated allocation. Both the participants and the study team will remain blinded to group assignment.

Group A (Placebo): Participants will receive 10 doses (30 capsules total) of microcrystalline cellulose (placebo), to be taken daily from postoperative day (POD) 1 through POD 10.

Group B (Oral TXA): Participants will receive 10 doses (30 capsules total) of oral TXA, dosed at 1.95 g per day (650 mg per capsule, 3 capsules daily) from POD 1 through POD 10.

All participants will receive standard intraoperative care, including 1 gram IV TXA prior to skin incision and an additional 1 gram IV TXA at surgical closure. Postoperative pain management will be administered per standard clinical practice and at the discretion of the treating surgical team.

Patient Population:

The study will enroll 100 patients aged 14 to 22 years undergoing isolated ACLR with a BTB autograft at Campbell Clinic Surgery Center and collaborating study sites.

Study Procedures:

Eligible patients will be identified via chart review and approached in clinic or via phone. Informed consent (and assent where applicable) will be obtained during a routine preoperative visit. Baseline data will be collected, including demographics and medical history. Participants will then be randomized and provided with study medication (oral TXA or placebo) to begin on POD 1.

Outcomes: 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.

Blinding and Allocation:

All capsules will be identical in appearance and packaging to maintain blinding. Randomization will be performed centrally and allocation concealed. Study staff, treating physicians, and patients will remain blinded until data analysis.

Safety Monitoring:

Participants will be monitored for adverse events throughout the study period. TXA is generally well tolerated but may pose thrombotic risk in susceptible individuals; exclusion criteria are designed to minimize this risk. The study team will report any serious adverse events (SAEs) to the IRB per institutional guidelines.

The study is powered to detect clinically meaningful differences in VAS scores, with a planned enrollment of 50 patients per group, allowing for a 20% loss to follow-up. This trial aims to clarify the role of extended postoperative oral TXA in reducing inflammation, pain, and bleeding in young ACLR patients, potentially offering a low-cost adjunct to current perioperative care.

Enrollment: 100 estimated patients

Sex: All

Ages: 14 to 22 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

100 participants in 2 patient groups, including a placebo group

Oral TXA

Experimental group

Description:

Participants in this arm will receive oral tranexamic acid (TXA), 1.95 g daily (three 650 mg capsules) from POD 1 to POD 10, for a total of 10 doses (30 capsules). All participants will also receive 1 g IV TXA before incision and 1 g IV TXA at surgical closure as part of standard care.

Treatment:

Drug: Tranexamic Acid (TXA)

Placebo

Placebo Comparator group

Description:

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). All participants will also receive 1 g IV TXA before incision and 1 g IV TXA at surgical closure as part of standard care.

Treatment:

Drug: Placebo