Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

Phase 4

Recruiting

• Conditions: Breast Cancer; Blood Loss, Surgical
• Interventions: Drug: Tranexamic acid; Drug: Placebo

• Registration Number: NCT06428682
• Lead Sponsor: University of Virginia

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-13
• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-05-13
• Study Completion: 2026-05-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TXA group	Tranexamic acid	Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA
Placebo group	Placebo	Women undergoing immediate or delayed free flap breast reconstruction and receiving same volume of IV saline

Primary Outcome Measures

Name	Time	Method
Transfusion rate	Typically 0-72 hours after surgery	Transfusion rate during hospital stay
Delta Hemoglobin	1 day after surgery	Post-op day 1 Hemoglobin - Pre-op Hemoglobin

Secondary Outcome Measures

Name	Time	Method
Length of Stay	typically 2-4 days	Total length of stay after surgery
Surgical complications	30 days after surgery	Thromboembolic event, hematoma, seroma, flap compromise/ failure

Trial Locations

Locations (1)

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States