Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT
Trial ID or NCT#
Status
Purpose
Subcutaneous enoxaparin is currently the gold standard for VTE chemoprophylaxis. However, the efficacy of chemoprophylaxis with subcutaneous enoxaparin is affected by patient-level factors, thus, resulting in VTE events despite guideline-compliant prophylaxis. A population at particular risk is the growing number of patients who undergo autologous breast reconstruction. Direct oral anticoagulants (DOAC) might be a less invasive, yet, more efficacious mode of chemoprophylaxis in this patient population. Hence, the proposed work has the potential to cause a paradigm shift in chemoprophylaxis guidelines in a large population of patients undergoing plastic surgery.
Official Title
A Randomized Controlled Trial Comparing Apixaban Versus Enoxaparin Following Microsurgical Breast Reconstruction
Eligibility Criteria
- - Adult (>18 years) women - Scheduled to undergo unilateral or bilateral microsurgical breast reconstruction with free abdominal flaps (i.e. muscle-sparing transverse rectus abdominis musculocutaneous [TRAM] and/or deep inferior epigastric artery perforator [DIEP]) flap) - Caprini score of 6 or greater.
- - Contraindication to the use of apixaban or enoxaparin - Active bleeding - History of bleeding disorder - History of coagulopathy - History of heparin-induced thrombocytopenia - History of liver disease - History of renal disease (creatinine clearance <30 mL/min; serum creatinine >1.6 mg/dL) - Major neurosurgical intervention (brain/spine) within the past 90 days - Ophthalmologic procedure within the past 90 days - Uncontrolled hypertension - History of alcohol and/or substance abuse - Need for therapeutic anticoagulation
Investigator(s)
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Contact
Arash Momeni, MD
650-723-6189
View on ClinicalTrials.gov