Tranexamic Acid for Facelift Surgery
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves topical application of tranexamic acid, it is less likely to interact with other medications. It's best to discuss your specific medications with the trial team.
Is tranexamic acid safe for use in humans?
How does the drug tranexamic acid differ from other treatments for facelift surgery?
Research Team
Friederike Luetzenberg,, MD
Principal Investigator
University of Minnesota
Jenna Van Beck, MD
Principal Investigator
University of Minnesota
Eligibility Criteria
This trial is for adults over 18 who choose to have a facelift and are considered fit for the surgery by their doctor. It includes those having additional procedures, but participants must speak English.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
TXA is applied to a randomly assigned side of the face during facelift surgery, with different concentrations and methods for each treatment group
Follow-up
Participants are monitored for blood loss and adverse effects such as flap epidermolysis, hair loss, or abnormal scar formation
Treatment Details
Interventions
- Tranexamic acid
Tranexamic acid is already approved in United States, European Union, Japan for the following indications:
- Heavy Menstrual Bleeding
- Menstrual Disorders
- Bleeding Disorder
- Factor IX Deficiency
- Hemophilia A
- Melasma
- Heavy Menstrual Bleeding
- Menstrual Disorders
- Bleeding Disorder
- Factor IX Deficiency
- Hemophilia A
- Melasma
- Postpartum hemorrhage
- Heavy Menstrual Bleeding
- Menstrual Disorders
- Bleeding Disorder
- Factor IX Deficiency
- Hemophilia A
- Melasma
- Postpartum hemorrhage
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor