NCT03646409

Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 542 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thromboembolism
• Esophagus Cancer
• Bleeding
• Chemotherapy Effect

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-11
• Primary completion: 2018-10-01
• Completion: 2018-12-01
• First posted: 2018-08-24
• Last updated: 2020-01-13

Locations

1 site across 1 country: Netherlands