Impact of Topical Tranexamic Acid in Breast Reconstruction

NCT05807074 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: 228012NCI-2023-02817
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Reconstruction; Mastectomy

Outcome Measures

Primary Outcomes (2)

• Number of Breast Pockets That Develop a Hematoma

  Presence of hematoma in the surgical area within a 30-day period from time of treatment application in the operating room will be reported.

  Up to 1 month

• Number of Breast Pockets That Develop a Seroma

  Presence of seroma in the surgical area within 3-month period from time of treatment application in the operating room will be reported.

  Up to 3 months

Secondary Outcomes (5)

• Number of Breast Pockets That Developed Ecchymosis

  Up to 1 year

• Median Total Drain Output

  Approximately 1 month

• Median Total Drain Duration

  Approximately 1 month

• Number of Participants Requiring Reoperation After Completion of Bilateral Mastectomy

  Up to 1 year

• Proportion of Participants With Reported Infection in Surgical Area Post-mastectomy

  Up to 1 year

Study Arms (1)

All participants

EXPERIMENTAL

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.

Drug: Tranexamic Acid; Other: Saline

Interventions

Tranexamic Acid DRUG

Applied intraoperatively

Also known as: TXA, Lysteda

All participants

Saline OTHER

Applied intraoperatively

Also known as: Saline solution, Sodium Chloride 0.9%

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed breast malignancy OR increased risk for breast cancer
• Age \>= 18 years
• Scheduled to undergo bilateral mastectomy with plastic surgery closure or reconstruction
• Ability to understand a written informed consent document, and the willingness to sign it
• At least 4 weeks post-completion of chemotherapy or radiation therapy

You may not qualify if:

• Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study
• Any history of thromboembolic disease
• Current anticoagulant use
• Current use of chlorpromazine due to label contraindication
• Current use of any prothrombotic medical products due to label contraindication
• Documented or reported allergic reaction to tranexamic acid
• Male participants

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tranexamic Acid; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Study closed to enrollment earlier than expected due to slow accrual. As a result, all participants received the same intervention.

Results Point of Contact

• Title: Dr. Merisa Piper, MD
• Organization: University of California, San Francisco

Merisa.Piper@ucsf.edu

(415) 353-4320

Study Officials

• Merisa Piper, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 10, 2023
• Study Start: April 20, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: September 29, 2025
• Results First Posted: September 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)