Tranexamic Acid for Breast Reconstruction

Overseen By Serena Bhaskerrao

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Must not be taking: Anticoagulants, Chlorpromazine, Prothrombotics

Disqualifiers: Thromboembolic disease, Allergic to TXA, Male, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Intra-operative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether applying tranexamic acid (TXA) directly to the surgical area can reduce bleeding and fluid buildup after breast reconstruction surgery. It targets women undergoing simultaneous removal and reconstruction of both breasts, often due to cancer or high cancer risk. TXA, a medication that aids blood clotting, might prevent common complications like hematomas (blood collections) and seromas (fluid collections), which can disrupt healing and delay further treatments. Women diagnosed with breast cancer or at high risk, planning a double mastectomy with reconstruction, are suitable candidates for this study. As a Phase 4 trial, the study involves an FDA-approved treatment, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

If you are currently taking anticoagulants, chlorpromazine, or any prothrombotic medications, you will need to stop these to participate in the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What is the safety track record for Tranexamic Acid?

Studies have shown that tranexamic acid (TXA) is safe for use in breast surgeries, including the one in this trial. Research indicates that TXA reduces bleeding and the need for drainage after surgery. A review of ten years of data confirms that TXA is generally safe. Common side effects include mild headaches, stomach aches, and dizziness, which are considered minor.

Another study focused on breast reconstruction surgery also supported the safety of TXA, finding it commonly used without major safety concerns. Overall, TXA appears well-tolerated in breast surgeries, making it a promising option for reducing complications in these procedures. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Tranexamic Acid is unique because it actively targets bleeding by helping the blood clot more effectively. Most treatments for managing bleeding during breast reconstruction rely on general surgical techniques or other medications that may not be specifically tailored for this purpose. Researchers are excited about Tranexamic Acid because it is applied directly to the surgical site, potentially reducing blood loss more efficiently and improving recovery time. This targeted approach not only enhances patient safety but also optimizes surgical outcomes, making it a promising option in the field of reconstructive surgery.

What evidence suggests that applying tranexamic acid topically is effective for reducing post-operative bleeding and fluid collections in breast reconstruction?

Research has shown that tranexamic acid (TXA) reduces bleeding after breast surgery. Studies have found that TXA significantly lowers the risk of hematomas, or blood pooling under the skin, compared to not using it. It also decreases the amount of fluid needing drainage after surgery. In this trial, each participant will have one breast pocket exposed to TXA and the other to saline only before closure. Applying TXA directly to the surgical area helps blood clot, preventing issues like hematomas and fluid build-up, known as seromas. These benefits can lead to better healing and lower infection risk after mastectomy and breast reconstruction. Overall, TXA is a reliable option for managing bleeding after breast surgery. ^{2 3 6 7 8}

Who Is on the Research Team?

Merisa Piper, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for women over 18 who are having both breasts removed and reconstructed due to breast cancer or high risk of it. They must understand and sign a consent form, be at least 4 weeks post-chemo or radiation, with no allergies to TXA, no current use of certain drugs like chlorpromazine or prothrombotic products, not on anticoagulants, and have no history of blood clots.

Inclusion Criteria

I am scheduled for a bilateral mastectomy with reconstruction.

Ability to understand a written informed consent document, and the willingness to sign it

It has been over 4 weeks since I finished my chemotherapy or radiation therapy.

Exclusion Criteria

Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study

I am currently taking blood thinners.

I am currently taking chlorpromazine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-operative treatment with topical TXA to one breast pocket, serving as their own control with saline applied to the other breast pocket

Intra-operative

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including seroma and hematoma formation, drain output, and infection rates

Up to 1 year

Regularly scheduled visits up to one year post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The study tests the effectiveness of applying Tranexamic Acid (TXA) topically during bilateral mastectomy followed by reconstruction. It aims to see if TXA can reduce bleeding and fluid collection after surgery compared to using saline solution.

How Is the Trial Designed?

Group I: All participants Experimental Treatment 2 Interventions

Each participant will have one breast pocket exposed to TXA and the other to saline only prior to closure. During surgery and prior to wound closure, the wound surface will be moistened on one side with 20 cc of dilute TXA 25mg/ml solution, and the contralateral with 20cc of saline.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1526820925000205

Tranexamic Acid in Breast Surgery – A Systematic Review ... The results demonstrate that both forms of TXA significantly reduce hematoma formation and reduce drain output and time until drain removal in breast surgery.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36729428/

Tranexamic Acid Use in Breast Surgery: A Systematic ... Perioperative intravenous administration of TXA significantly reduced the risk for hematoma (7.3% versus 12.9%; OR, 0.43; 95% CI, 0.23 to 0.81) ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681525001949

Review The current state of tranexamic acid in mastectomy ... TXA administration was found to significantly reduce postoperative hematoma formation, drain duration, and 24-hour drain output, without impacting seroma or SSI ...

4. nesps.org nesps.org/meeting/program/2025/77.cgi

Tranexamic Acid in Breast Surgery: 10 Years of ... Conclusions: This decade-spanning meta-analysis of prospective studies provides robust evidence that TXA significantly reduces hematoma and seroma rates in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04918589

Tranexamic Acid for Alloplastic Breast Reconstruction The primary objective of this study is to investigate the use of topical application of tranexamic Acid (TXA) to the surgical wound as a means to decrease ...

6. link.springer.com link.springer.com/article/10.1007/s00238-022-02027-z

a case control study | European Journal of Plastic Surgery This study highlights the safety of the routine use of TXA in the setting of free flap breast reconstruction.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11298145/

Topical Tranexamic Acid (TXA) Decreases Time to Drain ... The overall complication profile of TXA is relatively benign and includes headaches, abdominal aches, and dizziness. One study noted a very slight, but ...

8. ps-rc.org ps-rc.org/meeting/program/2025/189.cgi

PSRC - The Current State Of Tranexamic Acid In Breast ... Outcomes assessed included postoperative hematoma, seroma, surgical site infection (SSI), drain output, and drain duration. Subgroup analyses for study type, ...