Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

  • STATUS
    Recruiting
  • End date
    Aug 26, 2022
  • participants needed
    106
  • sponsor
    Stanford University
Updated on 26 January 2021
anesthesia
anticoagulants
enoxaparin
apixaban
apixaban 2.5 mg
enoxaparin 40mg/0.4ml prefilled syringe

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.

Details
Condition Venous Thromboembolism, Thromboembolism
Treatment Apixaban 2.5 MG Oral Tablet, Enoxaparin 40Mg/0.4mL Prefilled Syringe
Clinical Study IdentifierNCT04504318
SponsorStanford University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 89 yrs?
Are you female?
Do you have any of these conditions: Venous Thromboembolism or Thromboembolism?
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
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