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

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Tinzaparin

• Registration Number: NCT03099031
• Lead Sponsor: LEO Pharma

Brief 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

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Primary Completion: 2017-05-15
• Study Completion: 2017-05-15
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• Cancer patients with histologically confirmed, active or evolving, solid or liquid tumour, or
• Suspected malignant tumour confirmed within a month of index VTE occurrence
• Treated with specific metastatic or adjuvant anti-cancer treatment
• Patients with recent diagnosis of documented symptomatic or incidental VTE and a prescription of tinzaparin for 6 months
• Proximal or distal VTE of lower limbs
• Pulmonary embolism
• Inferior or superior vena cava thrombosis
• Iliac vein thrombosis

Exclusion Criteria

• Skin cancer other than melanoma
• Life expectancy less than 6 months
• Superficial isolated thrombosis
• Isolated subsegmental pulmonary embolism
• Cerebral, visceral thrombosis
• Superior limbs VTE or Central catheter thrombosis
• Patients being treated with anticoagulants by more than 7 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tinzaparin	Tinzaparin	Patients with objectively confirmed cancer associated venous thromboembolism receiving tinzaparin treatment to prevent recurrence of venous thromboembolism

Primary Outcome Measures

Name	Time	Method
Venous thromboembolism recurrence	6 months

Secondary Outcome Measures

Name	Time	Method
Major hemorrhage	6 months
Death	6 months	All cause mortality
Heparin induced thrombocytopenia	6 months

Trial Locations

Locations (1)

George Pompidou European Hospital; 🇫🇷 Paris, France