Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer (VENETIA)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Completed

Conditions: Chemotherapy Effect; Esophagus Cancer; Venous Thromboembolism; Bleeding

Treatments: Other: Venous thromboembolic event, arterial thromboembolic event, bleeding events

Study type: Observational

Funder types: Other

Identifiers

NCT03646409

thromboembolism and bleeding

Details and patient eligibility

About

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.

Full 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.

Enrollment: 542 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Esophageal cancer patients
• Receiving chemotherapy
• Age at least 18 years old

Exclusion criteria

• Death <3 months after cancer diagnosis (baseline)

Trial design

542 participants in 1 patient group

Patients with esophageal cancer receiving chemotherapy

Description:

Patients \> 18 years with esophageal cancer receiving neoadjuvant chemotherapy

Treatment:

Other: Venous thromboembolic event, arterial thromboembolic event, bleeding events