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

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Blood Loss, Surgical
• Intervention / Treatment: Drug: Tranexamic acid; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rachel Park, MD; Phone Number: 5714287278; Email: RHP7GU@uvahealth.org

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • Recruiting
      • University of Virginia Medical Center
      • Contact: Rachel H Park, MD; Phone Number: 571-428-7278; Email: rhp7gu@hscmail.mcc.virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TXA group; Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA	Drug: Tranexamic 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.
Placebo Comparator: Placebo group; Women undergoing immediate or delayed free flap breast reconstruction and receiving same volume of IV saline	Drug: Placebo; Control group will receive same volume equivalent of saline intravenously at the time of their surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion rate	Transfusion rate during hospital stay	Typically 0-72 hours after surgery
Delta Hemoglobin	Post-op day 1 Hemoglobin - Pre-op Hemoglobin	1 day after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: John Stranix, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Estimated): May 13, 2025
• Study Completion (Estimated): May 13, 2026

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Tranexamic Acid; Free Flap; Autologous breast reconstruction
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: HSR220370

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes