for females ages 18 years and up (full criteria)
at San Francisco, California
study started
completion around
Principal Investigator
by Merisa Piper, MD
Headshot of Merisa Piper
Merisa Piper



Improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of Tranexamic Acid (TXA) in many surgical fields. This trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site (topically) works to reduce post-operative bleeding (hematomas) and fluid collections (seromas) in women undergoing surgery to remove both breasts (bilateral mastectomy) immediately followed by surgery to rebuild the breast (reconstruction). The formation of hematomas and seromas, a common post-mastectomy complication, can interfere with breast reconstruction and increase the risk of infection and wound healing and can potentially delay cancer treatments. TXA is a synthetic molecule that pushes the body's clotting cascade toward clot formation to improve blood clotting. Applying TXA topically to the surgical site before closing the incision may prevent hematoma and seroma formation in post-mastectomy breast reconstruction patients.

Participants will be recruited from patients undergoing bilateral mastectomy at University of California, San Francisco.

Official Title

The Impact of Tranexamic Acid in Reducing Hematoma and Seroma Formation in Reconstructive Post-oncologic Breast Surgery



  1. To investigate whether topical tranexamic acid may impact rates of seroma, hematoma, severe bruising, and drain output in the post-mastectomy reconstructive population.

II. To evaluate the impact of TXA on seroma rates compared to control.


  1. To evaluate the impact of TXA on patient and provider rating of bruising, comparing the TXA side to the control side.

II. To evaluate the impact of TXA on total drain output in the first post operative day.

III. To evaluate the impact of TXA on total drain duration.


Participants will only be treated intra-operatively at the time of surgery with topical TXA to one breast pocket. Each participant will serve as own internal control, with one side receiving saline and the other TXA. Participants in this study will be assessed at their regularly scheduled visits up to one year post-operatively.


Breast Cancer, Breast Reconstruction, Tranexamic Acid, Saline, TXA, Saline


You can join if…

Open to females ages 18 years and up

  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

You CAN'T join if...

  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


  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Merisa Piper, MD
    Dr. Merisa L. Piper is a plastic and reconstructive surgeon who specializes in breast reconstruction and general reconstruction, with expertise in all methods. With the goal of restoring appearance after partial or complete breast removal, she focuses particularly on microsurgery and free tissue transfer, using skin, fat and muscle from another part of the body.


accepting new patients
Start Date
Completion Date
University of California, San Francisco
Phase 4 Breast Cancer Research Study
Study Type
Expecting 150 study participants
Last Updated