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Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT
Not Recruiting
Trial ID: NCT04504318
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
Stanford Investigator(s)
Arash Momeni, MD, FACS
Associate Professor of Surgery (Plastic and Reconstructive Surgery)
Eligibility
Inclusion 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.
Exclusion Criteria:
* 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
Intervention(s):
drug: Apixaban 2.5 MG Oral Tablet
drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Arash Momeni, MD
650-723-6189