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Antifibrinolytic Agent
TXA for Gender Affirming Mastectomy (IVTXA Trial)
Phase 2
Recruiting
Led By Esther Kim, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients who undergo gender affirming mastectomy at UCSF
Age ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
IVTXA Trial Summary
This trial will evaluate the effectiveness and safety of TXA in reducing hematoma and seroma rates in patients undergoing gender affirming mastectomy (GAM).
Who is the study for?
This trial is for adults over 18 who are undergoing gender affirming mastectomy at UCSF and meet WPATH guidelines. It's not for those with a history of bleeding disorders, chest surgery, severe kidney issues, or allergies to TXA. Participants must be able to consent and should not have chronic anticoagulation or antiplatelet medication use.Check my eligibility
What is being tested?
The study tests if intravenous tranexamic acid (IV TXA) can reduce bleeding and fluid collection after gender affirming mastectomy. Patients will be randomly assigned to receive IV TXA or no treatment in this prospective randomized control trial.See study design
What are the potential side effects?
While the side effects of IV TXA aren't detailed here, common ones may include nausea, diarrhea, seizures in high doses, color vision disturbances, and an increased risk of blood clots.
IVTXA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a gender affirming mastectomy at UCSF.
Select...
I am 18 years old or older.
IVTXA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Clinically Significant Hematomas
Number of Participants with Clinically Significant Seromas
Time to Drain Removal
+1 moreIVTXA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IV TXA GroupExperimental Treatment1 Intervention
Patients in the experimental group will receive a loading dose of IV tranexamic acid (TXA) at a concentration of 1g/10ml over a period of 10 minutes, administered immediately following anesthesia induction. Postoperative care will be standard and based on established UCSF guidelines.
Group II: Control GroupActive Control1 Intervention
Patients in the control group will not receive any IV TXA intraoperatively and will undergo a traditional gender affirming mastectomy following the established standard of care.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,526 Previous Clinical Trials
15,244,475 Total Patients Enrolled
1 Trials studying Hematoma
47 Patients Enrolled for Hematoma
Esther Kim, MDPrincipal InvestigatorUCSF Department of Plastic & Reconstructive Surgery
2 Previous Clinical Trials
1,050 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: IV TXA Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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