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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: Recruiting Early Phase 1 study of Hemorrhage and Hemophilia, sponsored by University of Minnesota.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2026-07-01 |
| Phase | Early Phase 1 |
What NCT06345833 shows while recruiting
NCT06345833 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 264-participant average among 20 other Hemorrhage trials with a reported enrollment target (81% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06345833's enrollment target sits among peer trials
50 14th of 20 higher than 5 of 20 other Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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