Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

Breast Cancer Clinical Trial

Official title:

Role of Intravenous Tranexamic Acid Use in Patients Undergoing Breast Free Flap Reconstruction: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06428682
• Other study ID #: HSR220370
• Status: Recruiting
• Phase: Phase 4
• Start date: May 13, 2024
• Est. completion date: May 13, 2026

Study information

• Verified date: June 2024
• Source: University of Virginia
• Contact: Rachel Park, MD
• Phone: 5714287278
• Email: RHP7GU[@]uvahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tranexamic acid (TXA) is a synthetic, competitive lysine receptor inhibitor on plasminogen. It ultimately stabilizes the fibrin matrix, therefore used as a hemostatic agent for various indications. While there has been indications for orthopedic and trauma surgery, there is no clear data for its role in patients who are undergoing free tissue transfer. Studies have shown that patients undergoing free tissue transfer can have transfusion rates ranging from 7.2% to 34.9%, which data also showing association between transfusion requirement and higher free flap failure rate. There has been a few retrospective studies that evaluated the effect of TXA in free tissue transfer and the results showed no increased risk of microanastomosis failure but some showing decreased blood loss. This study aims to further analyze the role of TXA in patients undergoing breast free flap reconstruction with randomized, prospective trial. Control group will not receive TXA while experimental group will receive TXA. Both groups will receive standard of care breast free flap surgery as well as post-op care, which is streamlined with Early Recovery After Surgery (ERAS) protocol. Their pre and post-op hemoglobin will be compared, as well as rates of transfusion, surgical outcome and surgical complications including hematoma, flap failure, and any other medical complications such as Deep Vein Thrombosis (DVT)/ Pulmonary Embolism (PE).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 13, 2026
• Est. primary completion date: May 13, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center

Exclusion Criteria:

• Subjects with ages <18 years

• Allergy to TXA

• Subjects who has contraindications to TXA: anyone who has active intravascular thrombosis or anyone with subarachnoid hemorrhage

• Subjects who have anemia (defined as baseline hemoglobin <8 g/dL

• Subjects who cannot read or understand English

• Subjects who are pregnant

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Breast Cancer

Intervention

Drug:
• Tranexamic acid
Experimental group will receive TXA intraoperatively (15mg/kg IV, once at beginning of case then re dose at 4hrs if operation goes longer) at the time of their surgery.
• Placebo
Control group will receive same volume equivalent of saline intravenously at the time of their surgery.

Locations

Country	Name	City	State
United States	University of Virginia Medical Center	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta Hemoglobin	Post-op day 1 Hemoglobin - Pre-op Hemoglobin	1 day after surgery
Primary	Transfusion rate	Transfusion rate during hospital stay	Typically 0-72 hours after surgery
Secondary	Surgical complications	Thromboembolic event, hematoma, seroma, flap compromise/ failure	30 days after surgery
Secondary	Length of Stay	Total length of stay after surgery	typically 2-4 days