Extended Oral Tranexamic Acid After Anterior Cruciate Ligament Reconstruction

NCT07115056 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Oral TXA After ACL-R
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

ACL; ACL Repair; ACL Reconstruction; TXA; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  The Visual Analog Scale (VAS) is a validated patient-reported outcome measure used to assess pain intensity. Patients rate their pain on a scale from 0 (no pain) to 10 (worst imaginable pain).

  Pre-op and 2 week, 6 week, 12 week, 6 months, 1 year, 2 year post op

Secondary Outcomes (8)

• Knee Range of Motion

  Pre-op and 2-week, 6-week, 12-week, 6 months, 1-year post-op

• Quadriceps Strength

  Pre-op and 2-week, 6-week, 12-week, 6 months, 1-year post-op

• Isokinetic Strength

  6 months, 9 months, 1-year post-op

• Time to Straight Leg Raise

  Up to 1 year

• Time to Return to Sport

  Up to 1 year

Study Arms (2)

Oral TXA

EXPERIMENTAL

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.

Drug: Tranexamic Acid (TXA)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Tranexamic Acid (TXA) DRUG

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.

Oral TXA

Placebo DRUG

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).

Placebo

Eligibility Criteria

• Age: 14 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:

• 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

Sponsors & Collaborators

• Campbell Clinic: lead
• Duke University: collaborator
• University of Pittsburgh: collaborator
• Endeavor Health: collaborator
• University of Cincinnati: collaborator
• Washington University School of Medicine: collaborator

Study Sites (6)

Endeavor Health

Evanston, Illinois, 60201, United States

Location

Washington University School of Medicine in St. Louis

Chesterfield, Missouri, 63017, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27705, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

Related Publications (8)

• Vermeijden HD, Yang XA, Rademakers MV, Kerkhoffs GMMJ, van der List JP, DiFelice GS. Early and Delayed Surgery for Isolated ACL and Multiligamentous Knee Injuries Have Equivalent Results: A Systematic Review and Meta-analysis. Am J Sports Med. 2023 Mar;51(4):1106-1116. doi: 10.1177/03635465211069356. Epub 2022 Jan 31.

  PMID: 35099334 BACKGROUND

• Tan TK, Ng KT, Lim HJ, Radic R. Effect of tranexamic acid in arthroscopic anterior cruciate ligament repair: A systematic review and meta-analysis of randomised clinical trials. J Orthop Surg (Hong Kong). 2021 May-Aug;29(2):23094990211017352. doi: 10.1177/23094990211017352.

  PMID: 34027721 BACKGROUND

• Romereim SM, Smykowski MR, Ball EK, Carey EG, Cuadra M, Williams A, Hickson K, Haim K, Sumith M, Yu Z, Jin G, Foureau D, Steuerwald N, Odum S, Fearing BV, Riboh JC. Immunophenotyping of Synovial Tissue in Adolescents Undergoing ACL Reconstruction: What Is the Role of Synovial Inflammation in Arthrofibrosis? Am J Sports Med. 2025 Feb;53(2):315-326. doi: 10.1177/03635465241305411. Epub 2025 Jan 7.

  PMID: 39772756 BACKGROUND

• Kirwan MJ, Diltz ZR, Dixon DT, Rivera-Peraza CA, Gammage CJ, Mihalko WM, Harkess JW, Guyton JL, Crockarell JR, Ford MC. The AAHKS Clinical Research Award: Extended Postoperative Oral Tranexamic Acid in Total Knee Arthroplasty: A Randomized Controlled Pilot Study. J Arthroplasty. 2024 Sep;39(9S2):S13-S17. doi: 10.1016/j.arth.2024.02.073. Epub 2024 Feb 29.

  PMID: 38430972 BACKGROUND

• Keays SL, Mellifont DB, Keays AC, Stuelcken MC, Lovell DI, Sayers MGL. Long-term Return to Sports After Anterior Cruciate Ligament Injury: Reconstruction vs No Reconstruction-A Comparison of 2 Case Series. Am J Sports Med. 2022 Mar;50(4):912-921. doi: 10.1177/03635465211073152. Epub 2022 Feb 11.

  PMID: 35148249 BACKGROUND

• Goldstein K, Jones C, Kay J, Shin J, de Sa D. Tranexamic Acid Administration in Arthroscopic Surgery Is a Safe Adjunct to Decrease Postoperative Pain and Swelling: A Systematic Review and Meta-analysis. Arthroscopy. 2022 Apr;38(4):1366-1377.e9. doi: 10.1016/j.arthro.2021.10.001. Epub 2021 Oct 14.

  PMID: 34655767 BACKGROUND

• Felli L, Revello S, Burastero G, Gatto P, Carletti A, Formica M, Alessio-Mazzola M. Single Intravenous Administration of Tranexamic Acid in Anterior Cruciate Ligament Reconstruction to Reduce Postoperative Hemarthrosis and Increase Functional Outcomes in the Early Phase of Postoperative Rehabilitation: A Randomized Controlled Trial. Arthroscopy. 2019 Jan;35(1):149-157. doi: 10.1016/j.arthro.2018.07.050.

  PMID: 30611343 BACKGROUND

• Cen L, Liu H, Li M, Zhang YF, Zhang HJ, Huang ZY. Intraoperative tranexamic acid reduces postoperative haemarthrosis and improves early functional outcomes in double-bundle anterior cruciate ligament reconstruction. J Orthop. 2024 Dec 10;65:51-56. doi: 10.1016/j.jor.2024.12.005. eCollection 2025 Jul.

  PMID: 39801905 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Staff

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 11, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)