Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy

NCT05794321 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 23-38580
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 Hematoma; Postoperative Seroma

Keywords

Gender Affirming Mastectomy; Tranexamic Acid; IV TXA

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Clinically Significant Hematomas

  Hematoma will be defined as a collection of blood outside of blood vessels that requires intervention such as aspiration or surgical drainage. Hematomas that are smaller or that resolve without intervention will not be included in the analysis. All patients will undergo a physical examination during their postoperative clinic visits to assess for hematoma formation. Patients who develop symptoms of hematoma after discharge will be instructed to seek medical attention immediately. Hematoma will be assessed immediately after mastectomy, and then at their one week postoperative clinic visit. Patients will also be instructed to report any symptoms of hematoma to their healthcare provider after discharge. Data on hematoma will be collected as a binary outcome (yes/no), as well as the size of the hematoma and type of intervention. Statistical analysis will be used to determine the factors associated with hematoma development after mastectomy.

  Up to 3 months

• Number of Participants with Clinically Significant Seromas

  Seroma will be defined as a collection of fluid that accumulates in the surgical site after mastectomy that requires intervention such as aspiration or surgical drainage. Seromas that are smaller or that resolve without intervention will not be included in the analysis. All patients will undergo a physical examination during their postoperative clinic visits to assess for seroma formation. Seroma will be assessed immediately after mastectomy, and then at their one postoperative clinic visit. Patients will also be instructed to report any symptoms of seroma to their healthcare provider after discharge. Data on seroma will be collected as a binary outcome (yes/no), as well as the type of intervention, and the duration of symptoms. Statistical analysis will be used to determine the factors associated with seroma development after mastectomy.

  Up to 3 months

• Total Patient Drain Output

  Drain output will be defined as the amount of fluid (in milliliters) collected in surgical drains after mastectomy. The volume of fluid collected will be recorded by patients daily until the drains are removed. All patients will have surgical drains placed after mastectomy. Patients will be instructed to report any unusual drainage or bleeding to their healthcare provider. Data on drain output will be collected as a continuous variable, as well as the duration of drain placement. Statistical analysis will be used to determine the factors associated with increased drain output after mastectomy.

  Up to 3 months

• Time to Drain Removal

  Time to drain removal will be defined as the number of days from mastectomy surgery to the day the surgical drains are removed. The timing of drain removal will be determined by the primary surgeon, based on the amount and character of fluid collected in the drain, and the presence of factors such as infection, hematoma, or seroma. However, drains will typically be removed when they have produced \< 30cc/day for at least 3 days. The timing of drain removal will be recorded by nursing staff at the time of removal. Data on time to drain removal will be collected as a continuous variable, as well as the reason for early or delayed drain removal. Statistical analysis will be used to determine the factors associated with longer time to drain removal after mastectomy.

  Up to 3 months

Study Arms (2)

IV TXA Group

EXPERIMENTAL

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.

Drug: Intravenous TXA

Control Group

NO 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.

Interventions

Intravenous TXA DRUG

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.

IV TXA Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years of age
• All patients who undergo gender affirming mastectomy at UCSF
• ASA I-III,
• Ability to understand a written informed consent document, and the willingness to sign it.
• Patients who fulfil WPATH guidelines/criteria for undergoing GAM. WPATH Criteria include: Persistent, well-documented gender dysphoria; capacity to make a fully informed decision and to consent for treatment; age of majority in a given country; if significant medical or mental health concerns are present, they must be reasonably well controlled; 12 continuous months of hormone therapy as appropriate to the patient's gender goals (for two referrals by a mental health professional).

You may not qualify if:

• \<18 years old
• Unable to consent for themselves
• History of coagulopathy or bleeding disorders
• History of thromboembolic events including deep vein thrombosis or pulmonary embolism.
• Patients who are chronically anticoagulated, are on antiplatelet medications or have ever had an adverse reaction to IV TXA.
• Prior history of chest surgery.
• Known hypersensitivity or allergy to TXA
• Patients with severe renal impairment .

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Department of Plastic & Reconstructive Surgery

San Francisco, California, 94131, United States

RECRUITING

Related Links

• Gender-Affirming Mastectomy in Transmasculine Patients
• Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial
• Early Postoperative Outcomes of Breast Cancer Surgery in a Developing Country
• The Use of Hemostatic Agents to Decrease Bleeding Complications in Breast Cancer Surgery
• U.S. Sex Reassignment Surgery Market Size, Share \& Trends Analysis Report by Gender Transition (Male To Female, Female To Male), and Segment Forecasts, 2022-2030
• Efficacy of Tranexamic Acid in Reducing Seroma and Hematoma Formation Following Reduction Mammaplasty
• The Usage of Intravenous Tranexamic Acid in Reduction Mammaplasty Safely Reduces Hematoma Rates
• Intravenous Tranexamic Acid in Implant-Based Breast Reconstruction Safely Reduces Hematoma without Thromboembolic Events
• Tranexamic Acid general StatPearls

Study Officials

• Esther Kim, MD

  UCSF Department of Plastic & Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay A Tao, BS

CONTACT

4082755270; lindsay.tao@ucsf.edu

Carolyn Cafro, BS

CONTACT

7603300915; carolyn.cafro@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are randomly assigned to treatment arms. One treatment arm will include the use of IV TXA, the other treatment arm will receive the standard of care for treatment. Patients then remain in that same treatment arm throughout the course of the study

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: September 28, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)