Actively Recruiting
Role of Intravenous Tranexamic Acid Use in Patients Undergoing Breast Free Flap Reconstruction: Randomized Controlled Trial
Led by University of Virginia · Updated on 2024-06-05
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of tranexamic acid (TXA), a synthetic medicine that helps reduce bleeding, in women undergoing breast free flap reconstruction surgery. This study aims to understand if TXA can lower blood loss and transfusion rates without increasing complications like flap failure or blood clots. The trial is randomized and controlled to compare outcomes between patients receiving TXA and those receiving a placebo. Participants will be divided into two groups. One group will receive intravenous TXA during surgery at a dose of 15 mg/kg, with a possible second dose after 4 hours if the operation lasts longer. The other group will receive an equal volume of saline as a placebo. Both groups will have the same standard breast reconstruction surgery and postoperative care based on the Early Recovery After Surgery protocol. During the study, researchers will monitor changes in hemoglobin levels one day after surgery and track transfusion rates within 72 hours. They will also observe surgical complications such as hematoma, flap failure, and blood clots for up to 30 days, along with the length of hospital stay. These measures will help assess the effects of TXA on surgical outcomes and patient recovery.
CONDITIONS
Brief Title
Role of TXA in Patients Undergoing Breast Free Flap Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Undergoing unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center
You will not qualify if you...
- Age under 18 years
- Allergy to tranexamic acid (TXA)
- Active intravascular thrombosis or subarachnoid hemorrhage
- Anemia with baseline hemoglobin less than 8 g/dL
- Inability to read or understand English
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 4 hours or duration of surgery
Participants undergo breast free flap reconstruction surgery and receive either intravenous tranexamic acid or placebo during the operation.
1 surgery visit (in-person)
Duration - Up to 30 days after surgery
Participants are monitored for surgical complications and recovery, including assessment of hemoglobin levels and transfusion needs after surgery.
Approximately 2 to 4 post-operative visits (in-person)
Trial Site Locations
Total: 1 location
1
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22902
Actively Recruiting
Research Team
R
Rachel Park, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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