Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery

• Status: Completed
• Trial end date: 2021-11-06
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, twin-center, cohort study in patients discharged from the hospital after major abdominal or pelvic cancer surgery for cancer. This study is designed to evaluate the adherence to extended deep vein thrombosis prophylaxis (DVT) with the direct oral anticoagulant apixaban on the background of historical data from the investigator's center on low-molecular-weight heparin (LMWH) substandard adherence in the same setting.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Treatments: Apixaban

Criteria

Inclusion Criteria:

• Patients of at least 18 years of age, discharged after hepato-biliary, colorectal or gynecology-oncology abdominal/pelvic surgery (laparoscopic or open) for cancer and considered at increased risk for VTE (e.g. previous history of VTE, residual cancer, slow mobilization, obesity, comorbidities).

• Written informed consent obtained.

Exclusion Criteria:

• Patient unable to take tablets, even if crushed.

• Active bleeding.

• Venous thromboembolism diagnosed during the hospitalization.

• Severe hepatic impairment (Child Pugh class C).

• Severe renal failure on dialysis or with calculated creatinine clearance <15 mL/min.

• Platelet count <50·109/L.

• Concomitant treatment with azole-antimycotics, e.g., ketoconazole, itraconazole, voriconazole, or posaconazole, and HIV protease inhibitors, e.g., ritonavir.