Using intravenous tranexamic acid to reduce complications in gender affirming mastectomy
Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy
This study is testing if giving a medication called tranexamic acid during gender affirming mastectomy can help reduce complications like bleeding and fluid buildup after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | cart |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05794321 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of intravenous tranexamic acid (TXA) in reducing postoperative complications such as hematoma and seroma in patients undergoing gender affirming mastectomy at UCSF. It is a single-center, prospective randomized controlled trial where eligible patients will be randomly assigned to receive either TXA or a control treatment. The study aims to evaluate outcomes including bleeding rates, drain output, and time to drain removal. By focusing on a specific patient population, the trial seeks to provide valuable insights into improving surgical outcomes for gender affirming surgeries.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who meet WPATH guidelines for gender affirming mastectomy and are undergoing the procedure at UCSF.
Not a fit: Patients with a history of coagulopathy, thromboembolic events, or those who are chronically anticoagulated will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce postoperative complications for patients undergoing gender affirming mastectomy.
How similar studies have performed: Previous studies in other surgical fields have shown success with the use of TXA, but this specific application in gender affirming mastectomy is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 .
Where this trial is running
San Francisco, California
- UCSF Department of Plastic & Reconstructive Surgery — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Esther Kim, MD — UCSF Department of Plastic & Reconstructive Surgery
- Study coordinator: Lindsay A Tao, BS
- Email: lindsay.tao@ucsf.edu
- Phone: 4082755270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.