Impact of Topical Tranexamic Acid in Breast Reconstruction

NCT ID: NCT05807074

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2024-11-30

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.

Detailed Description

PRIMARY OUTCOMES:

I. 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.

SECONDARY OUTCOMES:

I. 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.

OUTLINE:

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

All participants

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.

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

Applied intraoperatively

Saline

Intervention Type: OTHER

Applied intraoperatively

Interventions

Tranexamic Acid

Applied intraoperatively

Intervention Type: DRUG

Saline

Applied intraoperatively

Intervention Type: OTHER

Other Intervention Names

TXA; Lysteda; Saline solution; Sodium Chloride 0.9%

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merisa Piper, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2023-02817

Identifier Type: REGISTRY

Identifier Source: secondary_id

228012

Identifier Type: -

Identifier Source: org_study_id