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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Virginia
University of Virginia Medical Center
RECRUITING
Charlottesville
Contact Information
Primary
Rachel Park, MD
RHP7GU@uvahealth.org
5714287278
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2026-05-13
Participants
Target number of participants: 100
Treatments
Experimental: TXA group
Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA
Placebo_comparator: Placebo group
Women undergoing immediate or delayed free flap breast reconstruction and receiving same volume of IV saline
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov

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