Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy

23-38580

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.

2023-09-28

2024-05-01

2024-05-01

Recruiting

Early phase I

150

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 .

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2023-11-18