Recruiting
Phase 2

Tranexamic Acid

Sponsor:

UCLA

Code:

NCT05794321

Conditions

Postoperative Hematoma

Postoperative Seroma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Intravenous TXA

Study Details

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

Study ID

NCT05794321

Start date

Sep 28, 2023

Status verified date

Jun, 2026

Completion date

May, 2032

Anticipated

Primary completion date

May, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age ≥ 18 years of age
2. All patients who undergo gender affirming mastectomy at UCSF
3. ASA I-III,
4. Ability to understand a written informed consent document, and the willingness to sign it.
5. 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).

Exclusion Criteria:

1. <18 years old
2. Unable to consent for themselves
3. History of coagulopathy or bleeding disorders
4. History of thromboembolic events including deep vein thrombosis or pulmonary embolism.
5. Patients who are chronically anticoagulated, are on antiplatelet medications or have ever had an adverse reaction to IV TXA.
6. Prior history of chest surgery.
7. Known hypersensitivity or allergy to TXA
8. Patients with severe renal impairment .

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: IV TXA Group

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.

no intervention: Control Group

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

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.

Primary outcome measure

  • Number of Participants with Clinically Significant Hematomas [ Time Frame: Up to 3 months ]
  • Number of Participants with Clinically Significant Seromas [ Time Frame: Up to 3 months ]
  • Total Patient Drain Output [ Time Frame: Up to 3 months ]
  • Time to Drain Removal [ Time Frame: Up to 3 months ]

Central Contacts and Locations

Central contacts

Nathan S Ramrakhiani, BS

6507760834nathan.ramrakhiani@ucsf.edu

Lindsay A Tao, BS

4082755270lindsay.tao@ucsf.edu

Locations

UCSF Department of Plastic & Reconstructive Surgery

Recruiting

San Francisco, California, United States, 94131

Contacts

Esther Kim, MD

Esther.kim@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Gender Affirming Mastectomy
  • Tranexamic Acid
  • IV TXA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-06-04.