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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 below

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I had a gender affirming mastectomy at UCSF.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

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 more

IVTXA 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,507 Previous Clinical Trials

15,238,425 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

Hematoma Research Study Groups: IV TXA Group, Control Group

Hematoma Clinical Trial 2023: Tranexamic Acid Highlights & Side Effects. Trial Name: NCT05794321 — Phase 2

Tranexamic Acid (Antifibrinolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05794321 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What kind of risks are associated with intravenous tranexamic acid treatment?

"Our team has assigned a score of 2 to the safety profile of IV TXA Group, as there is only limited evidence supporting its security. As this trial is currently in Phase 2, no data exists suggesting efficacy."

Answered by AI

Are researchers enrolling any new participants in this trial right now?

"Sadly, the research outlined on clinicaltrials.gov is not currently searching for patients to join their study. The trial was first published on May 1st 2023 and was last amended on March 20th 2023. Though this investigation isn't enrolling participants presently, there are 58 other medical trials that need volunteers right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy

2023. "Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05794321.