NCT05794321 Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy
| NCT ID | NCT05794321 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, San Francisco |
| Condition | Postoperative Hematoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-09-28 |
| Primary Completion | 2032-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2023-09-28 with a primary completion date of 2032-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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 .
Contact & Investigator
Esther Kim, MD
PRINCIPAL INVESTIGATOR
UCSF Department of Plastic & Reconstructive Surgery
Frequently Asked Questions
Who can join the NCT05794321 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postoperative Hematoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05794321 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05794321 currently recruiting?
Yes, NCT05794321 is actively recruiting participants. Contact the research team at nathan.ramrakhiani@ucsf.edu for enrollment information.
Where is the NCT05794321 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05794321 clinical trial?
NCT05794321 is sponsored by University of California, San Francisco. The principal investigator is Esther Kim, MD at UCSF Department of Plastic & Reconstructive Surgery. The trial plans to enroll 150 participants.