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NCT05794321 · ClinicalTrials.gov registry record · Phase 2
Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy
A Phase 2 study of Postoperative Hematoma and Postoperative Seroma, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT05794321: Recruiting Phase 2 study of Postoperative Hematoma and Postoperative Seroma, sponsored by University of California, San Francisco.
NCT05794321 is a Phase 2 study of Postoperative Hematoma and Postoperative Seroma that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05794321, a Phase 2 study of Postoperative Hematoma and Postoperative Seroma, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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 pati
Primary Outcome
Hematoma will be defined as a collection of blood outside of blood vessels that requires intervention such as aspiration or surgical drainage. Hematomas that are smaller or that resolve without intervention will not be included in the analysis. All patients will undergo a physical examination during their postoperative clinic visits to assess for hematoma formation. Patients who develop symptoms of hematoma after discharge will be instructed to seek medical attention immediately. Hematoma will b
Conditions Studied
Interventions
- DRUG Intravenous TXA
Study Locations (1)
California
- UCSF Department of Plastic & Reconstructive Surgery - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-09-28 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What NCT05794321 shows while recruiting
NCT05794321 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
The record links to 2 conditions, with Postoperative Hematoma appearing as the primary indexed condition, and to 1 intervention - of which Intravenous TXA is the first listed.
NCT05794321 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05794321 about?
NCT05794321 is a clinical study titled "Investigating the Use of Intravenous Tranexamic Acid in Gender Affirming Mastectomy". 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 show...
What is the current status of trial NCT05794321?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2023-09-28. Estimated completion is 2026-05.
What conditions does trial NCT05794321 study?
This clinical trial studies the following conditions: Postoperative Hematoma, Postoperative Seroma.
What interventions are being tested in trial NCT05794321?
The interventions under investigation include: Intravenous TXA (DRUG).
Who is sponsoring clinical trial NCT05794321?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05794321 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05794321's enrollment target sits among peer trials
150 455th of 2000 higher than 1,511 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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