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Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy

NCT05794321 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-10-23

No results posted yet for this study

Summary

Gender affirming surgeries (GAS) have been steadily increasing in the US, with the gender affirming mastectomy (GAM) being the most common surgery performed. Complications associated with these surgeries include hematoma and seroma. Prior studies in orthopedics, plastic surgery, and trauma have shown significant reduction of bleeding and ecchymosis with the use of tranexamic acid (TXA). TXA is a synthetic amino acid that blocks plasminogen conversion to plasmin, to stabilize clot formation. The intravenous (IV) efficacy in reducing hematoma rates has been established in implant-based breast reconstruction, as well as in reduction mammaplasty. However, there are currently no studies investigating the use of IV TXA in patients undergoing GAM.

The investigators propose a single-center, prospective randomized control trial to evaluate the efficacy and safety of intravenous tranexamic acid in decreasing hematoma and seroma rates for top surgery patients at UCSF. Patients will be randomized into two groups, an experimental group receiving IV TXA and a control group that will not receive IV TXA.

Patients in the experimental group will receive a loading dose of tranexamic acid (TXA) at a concentration of 1g/10ml over a period of 10 minutes, administered immediately following anesthesia induction. Patients will be excluded if they have a history of coagulopathy, bleeding disorders or prior chest surgery. Demographic data, surgical characteristics, and postoperative outcomes will also be recorded and analyzed. The investigators hypothesize that the use of IV TXA will significantly reduce hematoma, seroma, postoperative drain output, and time to drain removal in patients undergoing GAM.

Aim 1: To evaluate the effectiveness of IV TXA in reducing intraoperative bleeding, post-operative hematoma and seroma formation, drain output, and time to drain removal in patients undergoing GAM.

Aim 2: To compare the incidence of thromboembolic events and wound complications between patients receiving IV TXA and those who do not after GAM.

Conditions

  • Postoperative Seroma
  • Postoperative Hematoma

Interventions

DRUG

Intravenous TXA

Patients in the experimental group will receive a loading dose of tranexamic acid (TXA) at a concentration of 1g/10ml over a period of 10 minutes, administered immediately following anesthesia induction.

Sponsors & Collaborators

Principal Investigators

  • Esther Kim, MD · UCSF Department of Plastic & Reconstructive Surgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-28
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05794321 on ClinicalTrials.gov