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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemorrhage; Hemophilia; Facelift Surgery
• Intervention / Treatment: Drug: 1%Tranexamic acid with standard local; Drug: 3% TXA; Drug: 1% TXA with local plus 3% TXA-soaked pledgets

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jenna Van Beck, MD; Phone Number: (612) 626-5900

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eligible participants will consist of all regular clinic patients who elect and are deemed fit by the surgeon to undergo facelift surgery, including patients undergoing ancillary procedures
• age 18 and older
• English speaking.

Exclusion Criteria:

• younger than 18
• previously had an adverse reaction to tranexamic acid
• non-English speaking
• patients who elect not to participate or withdraw from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine with saline as the control. Each face is treated as a split face and one half gets randomized to a TXA containing treatment group, so that each participant serves as his/her own control.	Drug: 1%Tranexamic acid with standard local; 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine with saline as the control.
Experimental: Group 2; 3% TXA on TXA-soaked pledgets applied for 10 minutes with saline as the control Each face is treated as a split face and one half gets randomized to a TXA containing treatment group, so that each participant serves as his/her own control.	Drug: 3% TXA; 3% TXA on TXA-soaked pledgets applied for 10 minutes with saline as the control.
Experimental: Group 3; 1% TXA with local plus 3% TXA-soaked pledgets with saline as the control Each face is treated as a split face and one half gets randomized to a TXA containing treatment group, so that each participant serves as his/her own control.	Drug: 1% TXA with local plus 3% TXA-soaked pledgets; 1% TXA with local plus 3% TXA-soaked pledgets with saline as the control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	measured through post-operative drain output, post-operative edema and ecchymosis. drain output is believed to be a more accurate representation of blood loss as it directly assesses the area in which TXA was applied as compared to intra-operative blood loss, which would be heavily influenced by bleeding from the skin incision.	2 weeks post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse effects of TXA rates	in the form of flap epidermolysis, hair loss, or abnormal scar formation (e.g. hypertrophic scars) at the incision sites post-operatively.	2 weeks post-op

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Jenna Van Beck, MD, University of Minnesota; Principal Investigator: Friederike Luetzenberg,, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: ENT-2024-32847

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No