NCT06479161

Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty

Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty on Postoperative Pain and Range of Motion: A Randomized Control Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Matthew Grosso, MD · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 * Exception: Administer 2 grams TXA in 50cc normal saline topically during the case for patients with a history of stent placed within one year of surgery. TXA postoperative day (POD) 1-3 \[Experimental group\] * Administer 1.95 grams oral (3- 650 mg tablets) TXA each morning for three days following surgery. * Patients discharged home before POD 3 will be sent home with remaining oral TXA doses. Placebo POD 1-3 \[Control group\] * Administer oral placebo (3 tablets) each morning for three days following surgery. * Patients discharged home before POD 3 will be sent home with remaining oral placebo doses.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Tranexamic acid	1.95 grams oral

Timeline

• Start date: 2024-06-10
• Primary completion: 2025-02-28
• Completion: 2025-03-30
• First posted: 2024-06-28
• Last updated: 2024-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study