Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer (VENETIA)
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|ClinicalTrials.gov Identifier: NCT03646409|
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment|
|Venous Thromboembolism Esophagus Cancer Bleeding Chemotherapy Effect||Other: Venous thromboembolic event, arterial thromboembolic event, bleeding events|
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.
|Study Type :||Observational|
|Actual Enrollment :||542 participants|
|Official Title:||Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer|
|Actual Study Start Date :||June 11, 2018|
|Actual Primary Completion Date :||October 1, 2018|
|Actual Study Completion Date :||December 1, 2018|
Patients with esophageal cancer receiving chemotherapy
Patients > 18 years with esophageal cancer receiving neoadjuvant chemotherapy
Other: Venous thromboembolic event, arterial thromboembolic event, bleeding events
Whether or not venous or arterial thromboembolic and bleeding events occur in patients with esophageal cancer receiving neoadjuvant chemotherapy
- VTE- and bleeding incidence [ Time Frame: from start of cancer diagnosis ]6- and 12-month VTE- and bleeding incidence
- Predictive performance of VTE risk factors and known prediction models [ Time Frame: from start cancer diagnosis ]To assess the predictive value of Khorana, modified Vienna-, and PROTECHT score in Predictive performance of VTE risk factors and known prediction models
- Predictive performance of bleeding risk factors and known prediction models [ Time Frame: from start cancer diagnosis ]Predictive performance of bleeding risk factors and known prediction models
- Arterial thromboembolism (ATE) incidence [ Time Frame: from start of cancer diagnosis ]6- and 12-month ATE incidence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646409
|Amsterdam, Netherlands, 1105 AZ|
|Principal Investigator:||Harry R Büller, Prof. dr.||Vascular Medicine|