Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Venous Thromboembolism
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Enrollment
- 542
- Locations
- 1
- Primary Endpoint
- VTE- and bleeding incidence
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study aims to assess the 6- and 12-month venous thromboembolism (VTE) and bleeding incidence from the start of cancer diagnosis in a retrospective cohort of patients with esophageal cancer. Additionally, the predictive value of the Khorana score and several other VTE and bleeding prediction scores and risk factors will be evaluated.
Detailed Description
Patients with cancer are at high risk of venous thromboembolism (VTE), including deep-vein thrombosis and pulmonary embolism. For cancer patients receiving chemotherapy the incidence of VTE is even higher. Several predictive models were previously developed to identify and justify thromboprophylaxis for cancer patietns who are at highest risk of VTE, like the Khorana and PROTECHT score. The Khorana score is a risk-stratification tool to select patients at high risk of VTE for thromboprophylaxis. The PROTECHT score takes cisplatin-based chemotherapy into account in addition of the Khorana score. Thereby, the incidence of bleeding and VTE in patients with esophageal cancer is not clear. This study aims to assess the 6- and 12-month venous thromboembolism (VTE) and bleeding incidence from the start of cancer diagnosis in a retrospective cohort of patients with esophageal cancer. Additionally, the predictive value of the Khorana score and several other VTE and bleeding prediction scores and risk factors will be evaluated.
Investigators
Harry R. Buller
Prof. dr. H.R. Büller, principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Eligibility Criteria
Inclusion Criteria
- •Esophageal cancer patients
- •Receiving chemotherapy
- •Age at least 18 years old
Exclusion Criteria
- •Death \<3 months after cancer diagnosis (baseline)
Outcomes
Primary Outcomes
VTE- and bleeding incidence
Time Frame: from start of cancer diagnosis
6- and 12-month VTE- and bleeding incidence
Secondary Outcomes
- Predictive performance of VTE risk factors and known prediction models(from start cancer diagnosis)
- Predictive performance of bleeding risk factors and known prediction models(from start cancer diagnosis)
- Arterial thromboembolism (ATE) incidence(from start of cancer diagnosis)