Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Apixaban Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure. |
Drug: Apixaban 2.5 MG Oral Tablet
Patients will be assigned to the respective study groups postoperatively upon arrival in the post-anesthesia care unit. Hence, surgeons are blinded at the time of surgery as to study group assignment. Chemoprophylaxis will continue for the duration of the hospitalization.
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Active Comparator: Enoxaparin Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure. |
Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe
Patients will be assigned to the respective study groups postoperatively upon arrival in the post-anesthesia care unit. Hence, surgeons are blinded at the time of surgery as to study group assignment. Chemoprophylaxis will continue for the duration of the hospitalization.
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Outcome Measures
Primary Outcome Measures
- Apixaban vs. Enoxaparin - Bleeding event [90-day events]
To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction
Secondary Outcome Measures
- Apixaban vs. Enoxaparin - Venous Thromboembolism (VTE) event [90-day events]
To examine the rate of VTE events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult (>18 years) women
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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)
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Caprini score of 6 or greater.
Exclusion Criteria:
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Contraindication to the use of apixaban or enoxaparin
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Active bleeding
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History of bleeding disorder
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History of coagulopathy
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History of heparin-induced thrombocytopenia
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History of liver disease
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History of renal disease (creatinine clearance <30 mL/min; serum creatinine >1.6 mg/dL)
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Major neurosurgical intervention (brain/spine) within the past 90 days
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Ophthalmologic procedure within the past 90 days
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Uncontrolled hypertension
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History of alcohol and/or substance abuse
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Need for therapeutic anticoagulation
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Stanford University Medical Center | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
Investigators
- Principal Investigator: Arash Momeni, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-49355