Impact of Topical Tranexamic Acid in Breast Reconstruction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Tranexamic Acid; Other: Saline

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 will be followed up for assessments weekly for the first 4 weeks to assess for development of any of the outcomes of interest and assess for drain removal, 6 weeks, 3 months and 1 year after surgery for study outcomes.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Catherine Lu Dugan; Phone Number: 877-827-3222; Email: catherine.ludugan@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Principal Investigator: Merisa Piper, MD
      • Contact: Catherine Lu Dugan; Phone Number: 877-827-3222; Email: catherine.ludugan@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TXA, Saline; Each participant will have one breast exposed to TXA in the breast pocket 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; Applied intraoperatively; Other Names: TXA; Lysteda; Other: Saline; Applied intraoperatively; Other Names: Sodium Chloride 0.9%; Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with hematoma	Presence of hematoma in 30 day period from time of application in the operating room will be reported	Up to 1 month
Number of participants with seroma	Presence of seroma within3 month period from time of application in the operating room will be reported	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Ecchymosis	Ecchymosis will be measured separately for the right and left breast at each post operative visit and documented. The observer will be blinded to the laterality of TXA. Both participant and provider will be asked to rank which side, the right or left side, has worse bruising. The frequency of ecchymosis for the right and left side will be reported descriptively.	Up to 1 year
Median total drain output	Total drain output over the life of the drain from drain placement in the operating room to discharge on post-operation day 1. Drains will be removed per standard practice at our institution which is when they have produced < 30cc/day for at least 3 days.	Up to 1 month
Median total drain duration	The median time of total drain duration from drain placement in the operating room to removal of the drain will be reported descriptively for the saline only and TXA treated breast.	Up to 1 month
Number of participants requiring reoperation	The number of participants requiring an additional operation related to the bilateral mastectomy will be reported.	Up to 1 year
Proportion of participants with reported infection	The proportion of participants with demonstrated infection related to the bilateral mastectomy will be reported	Up to 1 year

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Merisa Piper, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Breast Reconstruction
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 228012; NCI-2023-02817 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No