A Phase 3 interventional study of Tranexamic Acid and Placebo in Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture and Pain, sponsored by Dave Bernholt. Not yet recruiting at 6 sites in United States. Open to participants aged 14 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Dave Bernholt · Phase 3, Interventional, and Treatment
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:
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:
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 (Kirwan et al., 2024) 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.
521 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 169 are open to participants now.
This study's planned enrollment of 100 is above the median of 56 across 378 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →This is the only study on the registry with Dave Bernholt as lead sponsor.
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Exclusion Criteria:
Oral 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.
Drug: Tranexamic Acid
Three 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.
Drug: Placebo
Compounded 650 mg oral capsules (USP-grade TXA, microcrystalline cellulose filler), 1.95 g once daily POD 0-7.
Matching capsules containing microcrystalline cellulose NF, three once daily POD 0-7.
Postoperative pain (VAS)
Visual Analog Scale pain score, 0 (no pain) to 10 (worst pain); higher scores mean worse pain.
Time frame: 2 weeks after surgery
Opioid consumption
Total morphine milligram equivalents (MME) taken, calculated from home diary pill counts and verified by capsule count.
Time frame: Day of surgery through 2 weeks after surgery
Knee range of motion
Knee flexion and extension in degrees, measured by goniometer by an MD, PA or NP.
Time frame: 2 weeks after surgery
Plan to share: 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).
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid
Anterior Cruciate Ligament Injuries →