Blood Loss, Surgical, Breast Cancer
Conditions
Keywords
Autologous breast reconstruction, Free Flap, Tranexamic Acid
Brief summary
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).
Interventions
DRUGTranexamic acid
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.
DRUGPlacebo
Control group will receive same volume equivalent of saline intravenously at the time of their surgery.
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delta Hemoglobin | 1 day after surgery | Post-op day 1 Hemoglobin - Pre-op Hemoglobin |
| Transfusion rate | Typically 0-72 hours after surgery | Transfusion rate during hospital stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complications | 30 days after surgery | Thromboembolic event, hematoma, seroma, flap compromise/ failure |
| Length of Stay | typically 2-4 days | Total length of stay after surgery |
Countries
United States
Contacts
Primary ContactRachel Park, MD
Outcome results
None listed