NCT06345833

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

Recruiting now EARLY_PHASE1 Last updated 19 August 2025

What this trial tests

EARLY_PHASE1 trial testing 1%Tranexamic acid with standard local in Hemophilia in 50 participants. Currently enrolling.

Timeline

1 July 2024

Primary endpoint
1 July 2026

1 July 2026

Quick facts

Lead sponsor	University of Minnesota
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	50
Start date	1 July 2024
Primary completion	1 July 2026
Estimated completion	1 July 2026
Sites	1 location across United States

Drugs / interventions tested

• 1%Tranexamic acid with standard local — full drug profile →
• 3% TXA — full drug profile →
• 1% TXA with local plus 3% TXA-soaked pledgets — full drug profile →

Conditions studied

• Hemophilia — all drugs for Hemophilia →
• Hemorrhage — all drugs for Hemorrhage →
• Facelift Surgery — all drugs for Facelift Surgery →

Sponsor

University of Minnesota

Who can join

18 and older, any sex, with Hemophilia or Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.