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

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Contents

Study summaryTimelineTable: Further ResourcesReferences
clinicaltrials.gov/study/NCT06345833
Is a
‌
Clinical study
1

Clinical Study attributes

NCT Number
NCT063458331
Health Conditions in Trial
‌
Hemophilia
1
Trial Recruitment Size
501
Trial Sponsor
University of Minnesota
University of Minnesota
1
Clinical Trial Start Date
July 1, 2024
1
Primary Completion Date
July 1, 2026
1
Study Completion Date
July 1, 2026
1
Clinical Trial Study Type
Interventional1
Interventional Trial Purpose
Supportive Care1
Intervention Type
Drug1
Interventional Trial Phase
Early Phase 11
Official Name
Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study1
Last Updated
April 3, 2024
1
Allocation Type
Randomized1
Intervention Model
Parallel Assignment1
Masking Type
Double1
Masked Party
Outcomes Assessor1
Participant1

Other attributes

Intervention Treatment
1%Tranexamic acid with standard local1
3% TXA1
1% TXA with local plus 3% TXA-soaked pledgets1
Study 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.

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