Clinical trial NCT06345833: Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study
Official title: Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Hemophilia
Hemorrhage
Facelift Surgery
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Blood loss
timeFrame: 2 weeks post-op
Secondary outcomes:
measure: adverse effects of TXA rates
timeFrame: 2 weeks post-op
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jenna Van Beck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Friederike Luetzenberg,, MD
role: PRINCIPAL_INVESTIGATOR
References: