Status:
COMPLETED
Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery
Lead Sponsor:
McMaster University
Conditions:
Neoplasms Malignant
Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
All guidelines have embraced the concept of extended DVT prophylaxis after major abdominal or pelvic surgery for cancer, but the recommendation is consistently to use LMWH, which is more complicated t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2021
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04479579
Start Date
February 22 2021
End Date
November 6 2021
Last Update
April 22 2022
Active Locations (2)
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1
Thrombosis Service, HHS-General Hospital
Hamilton, Ontario, Canada, L8L 2X2
2
HHS-Juravinski Hospital
Hamilton, Ontario, Canada, L8V 1C3