RECRUITING

Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy

Quick Facts

Study Start:2023-09-28
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05794321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 years of age
  2. 2. All patients who undergo gender affirming mastectomy at UCSF
  3. 3. ASA I-III,
  4. 4. Ability to understand a written informed consent document, and the willingness to sign it.
  5. 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).
  1. 1. \<18 years old
  2. 2. Unable to consent for themselves
  3. 3. History of coagulopathy or bleeding disorders
  4. 4. History of thromboembolic events including deep vein thrombosis or pulmonary embolism.
  5. 5. Patients who are chronically anticoagulated, are on antiplatelet medications or have ever had an adverse reaction to IV TXA.
  6. 6. Prior history of chest surgery.
  7. 7. Known hypersensitivity or allergy to TXA
  8. 8. Patients with severe renal impairment .

Contacts and Locations

Study Contact

Israel O Falade, BS
CONTACT
6515834925
israel.falade@ucsf.edu

Principal Investigator

Esther Kim, MD
PRINCIPAL_INVESTIGATOR
UCSF Department of Plastic & Reconstructive Surgery

Study Locations (Sites)

UCSF Department of Plastic & Reconstructive Surgery
San Francisco, California, 94131
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Esther Kim, MD, PRINCIPAL_INVESTIGATOR, UCSF Department of Plastic & Reconstructive Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-28
Study Completion Date2025-05

Study Record Updates

Study Start Date2023-09-28
Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

  • Gender Affirming Mastectomy
  • Tranexamic Acid
  • IV TXA

Additional Relevant MeSH Terms

  • Postoperative Hematoma
  • Postoperative Seroma