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Anti-fibrinolytic agent

Tranexamic Acid for Breast Reconstruction

Phase 4
Recruiting
Led By John Stranix, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
Subjects with ages <18 years
Subjects who has contraindications to TXA: anyone who has active intravascular thrombosis or anyone with subarachnoid hemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day after surgery
Awards & highlights

Summary

This trial aims to study the effects of tranexamic acid (TXA) in patients undergoing breast free flap reconstruction. TXA is a medication that helps with blood clotting and reducing blood loss during

Who is the study for?
This trial is for patients undergoing breast reconstruction with free flap surgery after mastectomy due to breast cancer. Participants must not have a history of clotting or bleeding disorders, and should not be currently receiving anticoagulant therapy. They also need to be fit for the surgical procedure as per standard medical evaluation.
What is being tested?
The study is testing whether Tranexamic acid (TXA), a drug that helps reduce bleeding, can benefit patients during breast reconstruction surgery by comparing it with a placebo. The goal is to see if TXA reduces blood loss, the need for transfusions, and improves surgical outcomes without increasing risks like clot formation.
What are the potential side effects?
Potential side effects of TXA may include nausea, diarrhea, seizures in very rare cases if there are high doses in the bloodstream, and an increased risk of clots such as deep vein thrombosis (DVT) or pulmonary embolism (PE).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 18 planning to have breast reconstruction with abdomen tissue at UVA Medical Center.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 18 years old.
Select...
I do not have current blood clots or bleeding in the brain.
Select...
My hemoglobin level is below 8 g/dL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Delta Hemoglobin
Transfusion rate
Secondary outcome measures
Length of Stay
Surgical complications

Side effects data

From 2012 Phase 4 trial • 100 Patients • NCT00740116
22%
Readmissions
14%
Postoperative infections
10%
Re-operations
4%
Thromboembolic events
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group
Tranexamic Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TXA groupExperimental Treatment1 Intervention
Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA
Group II: Placebo groupPlacebo Group1 Intervention
Women undergoing immediate or delayed free flap breast reconstruction and receiving same volume of IV saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
2018
Completed Phase 4
~42540

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
771 Previous Clinical Trials
1,284,197 Total Patients Enrolled
John Stranix, MDPrincipal InvestigatorUniversity of Virginia
1 Previous Clinical Trials
117 Total Patients Enrolled
~58 spots leftby May 2025
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