Clinical trial NCT06428682: Role of TXA in Patients Undergoing Breast Free Flap Reconstruction
Official title: Role of Intravenous Tranexamic Acid Use in Patients Undergoing Breast Free Flap Reconstruction: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Breast Cancer
Blood Loss, Surgical
Keywords: Autologous breast reconstruction
Free Flap
Tranexamic Acid
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Delta Hemoglobin
timeFrame: 1 day after surgery
measure: Transfusion rate
timeFrame: Typically 0-72 hours after surgery
Secondary outcomes:
measure: Surgical complications
timeFrame: 30 days after surgery
measure: Length of Stay
timeFrame: typically 2-4 days
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: University of Virginia
name: John Stranix, MD
role: PRINCIPAL_INVESTIGATOR
References: