Using Tranexamic Acid to Reduce Blood Loss in Breast Reconstruction Surgery
Role of Intravenous Tranexamic Acid Use in Patients Undergoing Breast Free Flap Reconstruction: Randomized Controlled Trial
This study is testing if a medication called tranexamic acid can help reduce blood loss during breast reconstruction surgery for patients receiving free tissue transfer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06428682 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of tranexamic acid (TXA) in reducing blood loss during breast reconstruction surgeries using free tissue transfer. It involves a randomized, prospective design where one group of patients will receive TXA while the control group will receive a placebo. The study aims to determine if TXA can lower transfusion rates and improve surgical outcomes in patients undergoing this type of reconstruction. The research is being conducted at the University of Virginia Medical Center.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 years or older who are scheduled for unilateral or bilateral abdomen-based free flap breast reconstruction.
Not a fit: Patients who are under 18, have allergies to TXA, or have contraindications such as active intravascular thrombosis or anemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced blood loss and lower transfusion rates during breast reconstruction surgeries, improving patient outcomes.
How similar studies have performed: Previous studies have shown mixed results regarding the use of TXA in free tissue transfer, indicating that while some have shown decreased blood loss, the approach remains under-evaluated in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charlottesville, Virginia
- University of Virginia Medical Center — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: John Stranix, MD — University of Virginia
- Study coordinator: Rachel Park, MD
- Email: RHP7GU@uvahealth.org
- Phone: 5714287278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.