Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
NCT06428682

Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

Led by University of Virginia · Updated on 2024-06-05

100

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients 18 years or older
  • Scheduled for unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center
Not Eligible

You will not qualify if you...

  • Younger than 18 years
  • Allergy to tranexamic acid (TXA)
  • Active intravascular thrombosis or history of subarachnoid hemorrhage
  • Baseline hemoglobin less than 8 g/dL
  • Unable to read or understand English
  • Pregnant

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Virginia Medical Center

Charlottesville, Virginia, United States, 22902

Actively Recruiting

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Research Team

R

Rachel Park, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Role of TXA in Patients Undergoing Breast Free Flap Reconstruction | DecenTrialz