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Could a simple drug cut bleeding after mastectomy?

NCT ID NCT05807074

Symptom relief 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 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether applying tranexamic acid (TXA) directly to the surgical wound during breast removal and reconstruction can reduce bleeding (hematoma) and fluid collections (seroma). These complications can delay healing and cancer treatments. The trial enrolled 23 women at UCSF, but was terminated early, so results are limited.

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 offer a simple, low-cost way to reduce common complications after mastectomy and reconstruction.
What could go wrong
This was a small, terminated Phase 4 trial with only 23 participants, so results may not be reliable or apply to everyone. TXA can rarely cause blood clots or allergic reactions.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

23 people

The number who actually took part.

Started

Apr 2023

Finished

Nov 2024

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Histologically confirmed breast malignancy OR increased risk for breast cancer 2. Age \>= 18 years 3. Scheduled to undergo bilateral mastectomy with plastic surgery closure or reconstruction 4. Ability to understand a written informed consent document, and the willingness to sign it 5. At least 4 weeks post-completion of chemotherapy or radiation therapy Exclusion Criteria: 1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study 2. Any history of thromboembolic disease 3. Current anticoagulant use 4. Current use of chlorpromazine due to label contraindication 5. Current use of any prothrombotic medical products due to label contraindication 6. Documented or reported allergic reaction to tranexamic acid 7. Male participants

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • University of California, San Francisco

    San Francisco, California, 94143, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.