NCT03099031

Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)

Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 420 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to validate the Ottawa score (risk of thromboembolic recurrences) in cancer patients with thromboembolic disease treated with tinzaparin (Innohep®)

Detailed description

The Ottawa score is a clinical predictive score aiming at stratifying thromboembolic recurrences in cancer patients according to identified clinical risk factors and histological type of the tumor. This score has never been validated externally in a prospective way in patients treated with tinzaparin. The objective of this observational prospective study is to enroll cancer patients with TED treated with tinzaparin for a planned period of 6 months and to collect data on thromboembolic recurrences, major hemorrhages, deaths and heparin-induced thrombocytopenia

Conditions

• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Tinzaparin	Subcutaneous injection of 175 IU/kg once daily for 6 months

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-05-15
• Completion: 2017-05-15
• First posted: 2017-04-04
• Last updated: 2019-12-16

Locations

1 site across 1 country: France