AzTrials
AzTrials

Anterior Cruciate Ligament InjuriesPhase 3NCT07880743

Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction

A Phase 3 study testing Tranexamic Acid in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Dave Bernholt at 6 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to learn whether taking oral tranexamic acid (TXA) for one week after anterior cruciate ligament (ACL) reconstruction improves recovery in adolescents and young adults aged 14 to 25 years. All participants receive standard intravenous TXA during surgery. Read more about this study

Who is it for?
Ages 14 to 25 years
What is being tested?
Tranexamic Acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
6 sitesUnited States
Study dates
Nov 2026to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age 14 to 25 years with an ACL tear undergoing primary ACL reconstruction with bone-patellar tendon-bone autograft
  • Closed or closing proximal tibial and distal femoral physes on preoperative imaging (less than 1 year of growth remaining by MRI and radiographic bone age)
  • Weight of at least 100 lbs (45.4 kg)
  • Fluent in English

Who cannot join

  • Revision ACL reconstruction, multiligament knee reconstruction, or concurrent lateral extra-articular tenodesis or anterolateral ligament reconstruction
  • Concomitant meniscal repair or cartilage procedure requiring non-weightbearing or partial weightbearing after surgery (confirmed at the end of surgery, before randomization)
  • History of deep vein thrombosis or other thromboembolic event
  • History of renal impairment
  • History of seizure
  • Pregnant or breastfeeding
  • Known allergy or hypersensitivity to tranexamic acid
  • Use of combination hormonal contraception, tissue plasminogen activators, Factor IX complex or anti-inhibitor coagulant concentrates, or all-trans retinoic acid

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Research Manager contact

513-558-1933

UCOrtho@ucmail.uc.edu

6 sites in 1 country

United States6 sites

  • University of Cincinnati / UC Health Orthopaedics & Sports Medicine

    Cincinnati, Ohio, 45220

  • Duke University

    Durham, North Carolina, 27705

  • Campbell Clinic

    Germantown, Tennessee, 38138

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15215

  • Endeavor Health/NorthShore

    Skokie, Illinois, 60076

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction: A Multicenter Randomized Controlled Trial (SM25091)

The goal of this clinical trial is to learn whether taking oral tranexamic acid (TXA) for one week after anterior cruciate ligament (ACL) reconstruction improves recovery in adolescents and young adults aged 14 to 25 years. All participants receive standard intravenous TXA during surgery. The main questions it aims to answer are:

  • Does oral TXA lower knee pain at 2 weeks after surgery?
  • Does oral TXA reduce the amount of opioid pain medicine used in the first 2 weeks?
  • Does oral TXA improve knee range of motion at 2 weeks?
Read more

Researchers will compare oral TXA to a placebo (a look-alike capsule with no active drug) to see if oral TXA improves pain, opioid use, motion, strength, knee function, and return to sport.

Participants will:

  • Take 3 capsules (oral TXA or placebo) once a day for the first 8 days after surgery (day of surgery through day 7)
  • Keep a home diary for 2 weeks recording pain scores, opioid pills taken and any side effects
  • Return for study visits at 2 weeks, 6 weeks, 12 weeks, 6 months, 9 months and 1 year for pain, motion, strength and function testing
  • Complete a survey at 2 years
Read the detailed description

This multicenter, investigator-initiated, randomized, double-blind, placebo-controlled trial is conducted under IND 177715 at the University of Cincinnati (coordinating center) and five U.S. academic sites. One hundred participants undergoing isolated primary ACL reconstruction with bone-patellar tendon-bone autograft will be randomized 1:1 at the conclusion of surgery to oral TXA 1.95 g (three 650 mg capsules) once daily or matching microcrystalline cellulose placebo on postoperative days 0 through 7. All participants receive 1 g IV TXA before incision and 1 g IV TXA at closure, plus a standardized postoperative medication regimen.

Intraoperative IV TXA is established in ACL reconstruction for reducing pain and hemarthrosis. A pilot randomized trial in total knee arthroplasty found improved motion and outcome scores at 6 weeks with extended oral TXA. This trial tests whether a similar benefit applies to a younger, active ACL reconstruction population. Sample size is based on detecting a 2.0-point difference in VAS pain (SD 3.0), requiring 35 per group; 50 per group allows for about 20% loss to follow-up. Analysis is intention-to-treat.

Being tested
Tranexamic Acid, Placebo
Keywords
tranexamic acid, ACL reconstruction, bone-patellar tendon-bone autograft, antifibrinolytic, postoperative pain, opioid consumption, range of motion, hemarthrosis, arthrofibrosis, adolescent
Medical subject headings
Anterior Cruciate Ligament Injuries, Pain, Pain, Postoperative, Hemarthrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic AcidDrug

    Compounded 650 mg oral capsules (USP-grade TXA, microcrystalline cellulose filler), 1.95 g once daily POD 0-7.

  • PlaceboDrug

    Matching capsules containing microcrystalline cellulose NF, three once daily POD 0-7.

Study groups in NCT07880743
Study groupRoleWhat they receive
Oral TXAExperimentalOral TXA 1.95 g (three 650 mg capsules) once daily, POD 0 through POD 7 (8 doses, 24 capsules), in addition to standard IV TXA 1 g before incision and 1 g at closure and the standardized postoperative regimen.
Receives: Drug: Tranexamic Acid
PlaceboPlacebo comparatorThree matching microcrystalline cellulose capsules once daily, POD 0 through POD 7 (24 capsules), in addition to standard IV TXA 1 g before incision and 1 g at closure and the standardized postoperative regimen.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain (VAS)

    Visual Analog Scale pain score, 0 (no pain) to 10 (worst pain); higher scores mean worse pain.

    Measured: 2 weeks after surgery

  2. Opioid consumption

    Total morphine milligram equivalents (MME) taken, calculated from home diary pill counts and verified by capsule count.

    Measured: Day of surgery through 2 weeks after surgery

  3. Knee range of motion

    Knee flexion and extension in degrees, measured by goniometer by an MD, PA or NP.

    Measured: 2 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionNov 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07880743
Sponsor's protocol ID
SM25091
Other IDs
Sandy Kirkley Grant, UC IRB 2026-0967
Status last verified
Oct 2026
First submitted
12 Oct 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared; the protocol does not provide for data banking or sharing beyond the study team (Sec. 7.1).

Publications

  • Alkhatib N, AlNouri M, Abdullah ASA, Ahmad Alzobi OZ, Alkaramany E, Sasaki E, Ishibashi Y. Tranexamic Acid Use in Anterior Cruciate Ligament Reconstruction Decreases Bleeding Complications: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Arthroscopy. 2022 Feb;38(2):506-518.e6. doi: 10.1016/j.arthro.2021.07.030. Epub 2021 Aug 4.

    PubMed 34358640

  • Johns WL, Walley KC, Hammoud S, Gonzalez TA, Ciccotti MG, Patel NK. Tranexamic Acid in Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Am J Sports Med. 2021 Dec;49(14):4030-4041. doi: 10.1177/0363546521988943. Epub 2021 Feb 25.

    PubMed 33630652

  • 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(9 Suppl 2):S13-S17. doi: 10.1016/j.arth.2024.02.073. Epub 2024 Feb 29.

    PubMed 38430972

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tranexamic Acid in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Dave Bernholt at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Research Manager (513-558-1933, UCOrtho@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain (VAS) (time frame: 2 weeks after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07880743, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in