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NCT06345833 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of Hemorrhage and Hemophilia, sponsored by University of Minnesota.

Recruiting
Registry status
Early Phase 1
Development phase
50
Enrollment target
1
Study location

NCT06345833 is a Early Phase 1 study of Hemorrhage and Hemophilia that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 50 participants, below the 264-participant average among 20 other Hemorrhage trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06345833, a Early Phase 1 study of Hemorrhage and Hemophilia, is actively recruiting participants, sponsored by University of Minnesota.

RECRUITING
Registry status
Early Phase 1
Development phase
50 participants
Enrollment target
1
Study location

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.

Interventions

  • DRUG 1%Tranexamic acid with standard local
  • DRUG 3% TXA
  • DRUG 1% TXA with local plus 3% TXA-soaked pledgets

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2024-07-01
Est. Completion 2026-07-01
Phase Early Phase 1

Sponsor

University of Minnesota

966 total trials

What the Registry Record Tells You About NCT06345833

The ClinicalTrials.gov registry entry for NCT06345833 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 264-participant average among 20 other Hemorrhage trials with a reported enrollment target (81% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Hemorrhage appearing as the primary indexed condition, and to 3 interventions - of which 1%Tranexamic acid with standard local is the first listed.

NCT06345833 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT06345833 about?

NCT06345833 is a clinical study titled "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 fa...

What is the current status of trial NCT06345833?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2024-07-01. Estimated completion is 2026-07-01.

What conditions does trial NCT06345833 study?

This clinical trial studies the following conditions: Hemorrhage, Hemophilia, Facelift Surgery.

What interventions are being tested in trial NCT06345833?

The interventions under investigation include: 1%Tranexamic acid with standard local (DRUG), 3% TXA (DRUG), 1% TXA with local plus 3% TXA-soaked pledgets (DRUG).

Who is sponsoring clinical trial NCT06345833?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06345833 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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