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.* Ability to understand and the willingness to sign a written informed consent document.
- * 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* Pregnant or Nursing
Investigator(s)
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Contact
Arash Momeni, MD
650-723-6189
View on ClinicalTrials.gov