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

LEO Pharma

Status: Completed

Conditions: Venous Thromboembolism

Treatments: Drug: Tinzaparin

Study type: Observational

Funder types: Industry

Identifiers

NCT03099031

NIS-INNOHEP-1093

Details and patient eligibility

About

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®)

Full 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

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

420 participants in 1 patient group

Tinzaparin

Description:

Patients with objectively confirmed cancer associated venous thromboembolism receiving tinzaparin treatment to prevent recurrence of venous thromboembolism

Treatment:

Drug: Tinzaparin