Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

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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
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.

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

Intervention(s):

drug: Apixaban 2.5 MG Oral Tablet

drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Arash Momeni, MD
650-723-6189

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