TXA in Breast Free Flap Reconstruction

This study is looking at whether a medication called tranexamic acid (TXA) can help reduce blood loss and the need for blood transfusions during and after breast reconstruction surgery using your own tissue (free flap). TXA is a drug that helps blood clot. We know it helps in other surgeries, but we need more information for breast free flap surgery. You may be able to join if you are an adult woman having this type of breast reconstruction at UVA Medical Center. You cannot join if you are allergic to TXA or have certain medical conditions like a history of blood clots. The study will measure changes in your hemoglobin (a protein in red blood cells) one day after surgery and how many people need a blood transfusion up to 72 hours after surgery. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 100 women. Participants will be randomly assigned to receive either tranexamic acid or a placebo (saline) during surgery.
What's involved
Participants will receive either tranexamic acid or saline intravenously during their surgery. Blood tests will be taken to measure hemoglobin one day after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least one day after surgery for hemoglobin levels, and up to 72 hours for transfusion rates.

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NCT06428682

Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

UNKNOWN
PHASE4Ages 18+InterventionalTreatment
University of Virginia
~100 participants
Updated 2024-06-05 on ClinicalTrials.gov
What's tested:Tranexamic acidPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Delta Hemoglobin
Measured over 1 day after surgery
+1 more outcome measured
Breast Cancer
Blood Loss, Surgical
1 sites across 1 states
Virginia1
  • John Stranix, MD · PRINCIPAL_INVESTIGATOR · University of Virginia

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Eligibility criteria

Inclusion

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

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
  • Delta Hemoglobin1 day after surgery

    Post-op day 1 Hemoglobin - Pre-op Hemoglobin

  • Transfusion rateTypically 0-72 hours after surgery

    Transfusion rate during hospital stay