Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06428682
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tranexamic acid — DRUG
    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 — DRUG
    Control group will receive same volume equivalent of saline intravenously at the time of their surgery.

Study Details

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).

Key Dates

Start date
May 13, 2024
Status verified
Jun 2024
Primary completion
May 13, 2025
Completion
May 13, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Delta Hemoglobin [ Time Frame: 1 day after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Medical CenterCharlottesvilleVirginia22902
Rachel H Park, MD
[email protected]
571-428-7278

Find similar trials in Charlottesville, VA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Virginia Medical Center· Charlottesville, VA

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