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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Drug: Tinzaparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tinzaparin<br>Patients with objectively confirmed cancer associated venous thromboembolism receiving tinzaparin treatment to prevent recurrence of venous thromboembolism | Drug: Tinzaparin<br>* Subcutaneous injection of 175 IU/kg once daily for 6 months<br>* Other names: Innohep®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism recurrence |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major hemorrhage |  | 6 months | 
| Death | All cause mortality | 6 months | 
| Heparin induced thrombocytopenia |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ottawa score, tinzaparin, low-molecular weight heparin, anticoagulants, venous thrombosis, thromboembolism, hemostatic disorders, vascular disease, neoplasms, breast neoplasms, lung neoplasms, prostatic neoplasms, colorectal neoplasms, genital neoplasms, urogenital neoplasms, intestinal neoplasms, digestive system neoplasms, lymphoma, leukemia, multiple myeloma, lymphoproliferative disorders, myeloproliferative disorders, lymphatic disease