A Phase 2 interventional study of Tranexamic acid in Postoperative Pain, sponsored by Matthew Grosso, MD. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Matthew Grosso, MD · Phase 2, Interventional, and Treatment
The primary purpose of this study is to evaluate postoperative pain. Secondary outcomes evaluated in this study will include range of motion (ROM), opioid consumption, and ambulation. Each outcome measure will be evaluated, oral tranexamic acid (TXA) in the experiment arm and placebo in the control arm, after total knee arthroplasty (TKA) at postoperative days 0-3, and weeks 1, 2, 6, and 12.
Randomized controlled trial with 1:1 allocation, selected through computer-based randomization.
This study will review prospectively collected data, including patient demographic information, surgeon, use of oral tranexamic acid (TXA) or placebo regimen, and postoperative outcomes up to 3 months after surgery. Collaboration with Saint Francis' pharmacy team will be performed to ensure appropriate blinded administering of the oral TXA and placebo medication.
This will be a double blinded study, with both patient and surgeon blinded to study group.
6.0 TXA dosing protocol TXA day of surgery [All patients]
Administer 1-gram IV TXA intraoperatively at the start of the case (hold for history of stent within 1 year of surgery)
o AND
Administer 1-gram IV TXA postoperatively before leaving PACU (hold for history of stent within 1 year of surgery)
o OR
TXA postoperative day (POD) 1-3 [Experimental group]
Placebo POD 1-3 [Control group]
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 80 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with Matthew Grosso, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion for IV oral tranexamic acid (TXA):
Exclusion for oral TXA:
o Actively treated cancer or deep vein thrombosis (DVT)
- 1.95 grams oral TXA (tranexamic acid) (3- 650 mg tablets) administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use.
Drug: Tranexamic acid
- 3 tablets administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use.
Drug: Tranexamic acid
1.95 grams oral
Visual Analogue Scale (VAS) Pain scores
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain. Higher scores are a worse outcome.
Time frame: postoperative day (POD) 0, 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days).
Range of Motion
Clinical measurement of passive, pain-free range of motion of knee in degrees from 0 to 180 from maximum extension to maximum flexion
Time frame: at 2, 6 and 12 week follow up visits
Opioid consumption
Subjects will keep a log recording opioid consumption. Research staff will ask subjects to report opioids during postoperative telephone calls.
Time frame: POD 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days)
Ambulation Status
Surgeon or physical therapist will record if patient is using a walker, cane or no assistive devices.
Time frame: at 2, 6 and 12 week follow up visits
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