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Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy

University of California, San Francisco · NCT05794321

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
150
US sites recruiting
1
Study start
September 28, 2023
Record last updated
June 4, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Intravenous TXA

Conditions: Postoperative Hematoma; Postoperative Seroma

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • \<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 .

Recruiting US locations

  • UCSF Department of Plastic & Reconstructive Surgery

    San Francisco, CA 94131

    Site contact: Esther Kim, MD · Esther.kim@ucsf.edu

Study contacts (from the official record)

  • Nathan S Ramrakhiani, BS · 6507760834 · nathan.ramrakhiani@ucsf.edu
  • Lindsay A Tao, BS · 4082755270 · lindsay.tao@ucsf.edu
All healthy volunteers studies in California →
Investigating the Use of Intravenous Tranexamic Acid in Gender… (NCT05794321) | Bored Studies