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โ† Trials
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Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy

RecruitingPhase 2Ages 18 Years - anyFemaleUniversity of California, San Francisco
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In plain words

What the trial is, and whether it could suit you

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 i

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 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 .
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What it tests

  • Intravenous TXA
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Where

1 site
UCSF Department of Plastic & Reconstructive Surgery
San Francisco, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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