Gene Therapy Clinical Trials
Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT
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.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Apixaban 2.5 MG Oral Tablet
- drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe
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
Ages Eligible for Study
18 Years - 89 Years
Genders Eligible for Study
Female
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Arash Momeni, MD
650-723-6189
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