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

NCT ID: NCT06345833

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-07-01

Brief 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.

Conditions

Hemophilia; Hemorrhage; Facelift Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

1%Tranexamic acid with standard local

Intervention Type: DRUG

1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine with saline as the control.

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.

Group Type: EXPERIMENTAL

3% TXA

Intervention Type: DRUG

3% TXA on TXA-soaked pledgets applied for 10 minutes with saline as the control.

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.

Group Type: EXPERIMENTAL

1% TXA with local plus 3% TXA-soaked pledgets

Intervention Type: DRUG

1% TXA with local plus 3% TXA-soaked pledgets with saline as the control.

Interventions

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.

Intervention Type: DRUG

3% TXA

3% TXA on TXA-soaked pledgets applied for 10 minutes with saline as the control.

Intervention Type: DRUG

1% TXA with local plus 3% TXA-soaked pledgets

1% TXA with local plus 3% TXA-soaked pledgets with saline as the control.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jenna Van Beck, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Friederike Luetzenberg,, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jenna Van Beck, MD

Role: CONTACT

(612) 626-5900

Facility Contacts

Jenna Van Beck

Role: primary

Other Identifiers

ENT-2024-32847

Identifier Type: -

Identifier Source: org_study_id