Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study

Hemorrhage Clinical Trial

Official title: Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study

Status Not yet recruiting

Clinical Trial Summary

Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face.

Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events.[12] Given the low rate of adverse events while using TXA systemically, this protocol's application of TXA topically and/or locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Hemophilia
• Hemorrhage

• NCT number: NCT06345833
• Study type: Interventional
• Source: University of Minnesota
• Contact: Jenna Van Beck, MD
• Phone: (612) 626-5900
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 1, 2024
• Completion date: July 1, 2026