Clinical trial · Interventional
Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery
Towards Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Abdominal or Pelvic Major Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adherence, Medication | — | UNRESOLVED | — |
| Neoplasms Malignant | Malignant Neoplasm | ALIAS | 0.90 |
| Prophylaxis | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apixaban 2.5 milligram | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apixaban
- description
- apixaban for extended prophylaxis against VTE after discharge
- interventionNames
- Drug: Apixaban 2.5 milligram
Primary outcomes (2)
- measure
- Filled prescription
- timeFrame
- 1 week
- description
- Percent of included patients that have filled their prescription for apixaban
- measure
- At least 80% adherence
- timeFrame
- 30 days
- description
- Percent of patients with filled prescription that have at least 80% adherence
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDSerrano PE, Parpia S, Valencia M, Simunovic M, Bhandari M, Levine M. Incidence of delayed venous thromboembolic events in patients undergoing abdominal and pelvic surgery for cancer: a systematic review and meta-analysis. ANZ J Surg. 2019 Oct;89(10):1217-1223. doi: 10.1111/ans.15290. Epub 2019 Jun 18. PMID 31210407
- BACKGROUNDSerrano PE, Parpia S, Linkins LA, Elit L, Simunovic M, Ruo L, Bhandari M, Levine M. Venous Thromboembolic Events Following Major Pelvic and Abdominal Surgeries for Cancer: A Prospective Cohort Study. Ann Surg Oncol. 2018 Oct;25(11):3214-3221. doi: 10.1245/s10434-018-6671-7. Epub 2018 Jul 26. PMID 30051364
- RESULTSchulman S, Carlson V, Serrano PE, Sne N, Kahnamoui K, Mithoowani S, Ikesaka R, Gross PL. Adherence to apixaban for extended thromboprophylaxis after major abdominal or pelvic surgery for cancer: A prospective cohort study. J Surg Oncol. 2022 Aug;126(2):386-393. doi: 10.1002/jso.26876. Epub 2022 Apr 1. PMID 35362102