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New treatment option for Postoperative Hematoma
Official title Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy
ClinicalTrials.gov ID: NCT05794321
What this study is testing
What is Intravenous TXA?
Intravenous TXA is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for postoperative hematoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥ 18 years of age
- All patients who undergo gender affirming mastectomy at UCSF
- ASA I-III,
- Ability to understand a written informed consent document, and the willingness to sign it.
- Patients who fulfil WPATH guidelines/criteria for undergoing GAM. WPATH Criteria include: Persistent, well-documented gender dysphoria; capacity to...
You likely can't join if
- \<18 years old
- Unable to consent for themselves
- History of coagulopathy or bleeding disorders
- History of thromboembolic events including deep vein thrombosis or pulmonary embolism.
- Patients who are chronically anticoagulated, are on antiplatelet medications or have ever had an adverse reaction to IV TXA.
- Prior history of chest surgery.
See the full eligibility criteria
- Age ≥ 18 years of age
- All patients who undergo gender affirming mastectomy at UCSF
- ASA I-III,
- Ability to understand a written informed consent document, and the willingness to sign it.
- 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...
- \<18 years old
- Unable to consent for themselves
- History of coagulopathy or bleeding disorders
- History of thromboembolic events including deep vein thrombosis or pulmonary embolism.
- Patients who are chronically anticoagulated, are on antiplatelet medications or have ever had an adverse reaction to IV TXA.
- Prior history of chest surgery.
- Known hypersensitivity or allergy to TXA
- Patients with severe renal impairment .
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.