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


Description

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

Trial 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

Study Info

Organization

University of Virginia


Primary Outcome

Delta Hemoglobin


Outcome Timeframe 1 day after surgery

NCTID NCT06428682

Phases PHASE4

Primary Purpose TREATMENT

Start Date 2024-05-13

Completion Date 2025-05-13

Enrollment Target 100

Interventions

DRUG Tranexamic acid

DRUG Placebo

Locations Recruiting

University of Virginia Medical Center

United States, Virginia, Charlottesville


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