Extended Oral Tranexamic Acid After Anterior Cruciate Ligament Reconstruction
NCT ID: NCT07115056
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2026-04-01
2029-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Oral TXA
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.
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.
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). All participants will also receive 1 g IV TXA before incision and 1 g IV TXA at surgical closure as part of standard care.
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).
Interventions
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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.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
22 Years
ALL
No
Sponsors
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Duke University
OTHER
University of Pittsburgh
OTHER
Endeavor Health
OTHER
University of Cincinnati
OTHER
Washington University School of Medicine
OTHER
Campbell Clinic
OTHER
Responsible Party
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Frederick Azar
Chief of Staff
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Joe Lamplot, MD
Role: primary
Robert Brophy, MD
Role: primary
Brian Lau, MD
Role: primary
David Bernholt, MD
Role: primary
Brian Grawe, MD
Role: backup
Justin Arner, MD
Role: primary
Dylan Koolmees, MD
Role: primary
Emily Holmquist, MBA
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Oral TXA After ACL-R
Identifier Type: -
Identifier Source: org_study_id