Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

June 3, 2024 updated by: John Stranix, University of Virginia

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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