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Anti-fibrinolytic agent
Tranexamic Acid for Facelift Surgery
Phase < 1
Recruiting
Led By Jenna Van Beck, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
age 18 and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post-op
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the use of tranexamic acid (TXA) during facelift surgery to prevent prolonged bleeding. TXA will be applied to one side of the face in different forms,
Who is the study for?
This trial is for adults over 18 who choose to have a facelift and are considered fit for the surgery by their doctor. It includes those having additional procedures, but participants must speak English.
What is being tested?
The study tests Tranexamic acid (TXA) applied during facelifts to reduce bleeding. There are three ways TXA will be used: mixed with standard local anesthetic, as a higher concentration on soaked pledgets, or both methods combined.
What are the potential side effects?
While systemic use of TXA can increase blood clot risks in certain patients, this trial uses it topically or locally, which has not shown these adverse effects in previous studies on facial plastic surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks post-op
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood loss
Secondary study objectives
adverse effects of TXA rates
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment1 Intervention
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.
Group II: Group 2Experimental Treatment1 Intervention
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.
Group III: Group 1Experimental Treatment1 Intervention
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.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,434 Previous Clinical Trials
1,621,652 Total Patients Enrolled
Jenna Van Beck, MDPrincipal InvestigatorUniversity of Minnesota
Friederike Luetzenberg,, MDPrincipal InvestigatorUniversity of Minnesota
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