Impact of Topical Tranexamic Acid in Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05807074
• Other study ID #: 228012
• Secondary ID: NCI-2023-02817
• Status: Recruiting
• Phase: Phase 4
• Start date: April 20, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: Serena Bhaskerrao
• Phone: 877-827-3222
• Email: Serena.Bhaskerrao[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Tranexamic Acid
Applied intraoperatively

Other:
• Saline
Applied intraoperatively

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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