Status:
COMPLETED
Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT
Lead Sponsor:
Stanford University
Conditions:
Venous Thromboembolism
Eligibility:
FEMALE
18-89 years
Phase:
PHASE1
PHASE2
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, resu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2024
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04504318
Start Date
August 12 2020
End Date
June 19 2024
Last Update
June 22 2025
Active Locations (1)
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1
Stanford University Medical Center
Stanford, California, United States, 94305