Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Apixaban; Enoxaparin

Criteria

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