RecruitingPhase 4NCT06428682

Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

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


Sponsor

University of Virginia

Enrollment

100 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a medication called tranexamic acid (TXA) — which helps reduce bleeding — can lower the need for blood transfusions and reduce complications in women having breast reconstruction surgery using tissue taken from their own abdomen (a free flap procedure). **You may be eligible if...** - You are a woman aged 18 or older - You are scheduled to have one or both breasts reconstructed using abdominal tissue (a free flap) at UVA Medical Center **You may NOT be eligible if...** - You are under 18 years old - You are allergic to tranexamic acid - You have an active blood clot in a vein or artery, or have had a recent bleed in the brain (subarachnoid hemorrhage) - You have anemia (hemoglobin below 8 g/dL) - You cannot read or understand English - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTranexamic 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.

DRUGPlacebo

Control group will receive same volume equivalent of saline intravenously at the time of their surgery.


Locations(1)

University of Virginia Medical Center

Charlottesville, Virginia, United States

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NCT06428682


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