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Can a simple drug make top surgery safer? new trial investigates

NCT ID NCT05794321

Disease control Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether giving tranexamic acid (TXA) through an IV during gender affirming mastectomy (top surgery) can reduce complications like hematoma (blood collection) and seroma (fluid collection). 150 adults undergoing top surgery at UCSF will be randomly assigned to receive TXA or not. Researchers will track bleeding, drain output, and recovery time to see if TXA improves outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tranexamic acid (TXA)
What this could lead to
If it works, this could reduce complications like bleeding and fluid buildup after gender affirming mastectomy, leading to faster recovery.
What could go wrong
This is a small, early phase 2 trial. TXA may not reduce complications and carries a small risk of blood clots. Results may not apply to all surgery centers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

May 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 .

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postoperative hematoma Postoperative seroma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UCSF Department of Plastic & Reconstructive Surgery

    RECRUITING

    San Francisco, California, 94131, United States

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