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

NCT06345833 | Recruiting Early Phase 1

• 1 other identifier: ENT-2024-32847
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• adverse effects of TXA rates

  2 weeks post-op

Study Arms (3)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Group 3

EXPERIMENTAL

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

Interventions

1%Tranexamic acid with standard local DRUG

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

Group 1

3% TXA DRUG

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

Group 2

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

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

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Hemophilia A; Hemorrhage

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jenna Van Beck, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Friederike Luetzenberg,, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenna Van Beck, MD

CONTACT

(612) 626-5900

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (1)