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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®)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tinzaparin | Patients with objectively confirmed cancer associated venous thromboembolism receiving tinzaparin treatment to prevent recurrence of venous thromboembolism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tinzaparin | Drug | Subcutaneous injection of 175 IU/kg once daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Venous thromboembolism recurrence | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major hemorrhage | 6 months | |
| Death | All cause mortality | 6 months |
| Heparin induced thrombocytopenia |
| Measure | Description | Time Frame |
|---|---|---|
| Premature treatment discontinuation | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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Patient population from French general hospitals, anticancer centres, and university hospitals treating more than 1000 cancer patients per year
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| Name | Affiliation | Role |
|---|---|---|
| G Meyer, Professor | Service de pneumologie et de soins intensifs, Hôpital Européen Georges Pompidou, Paris | Principal Investigator |
| F Scotte, Dr | Unité fonctionnelle de soins oncologiques de support, Hôpital Européen Georges Pompidou, Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Pompidou European Hospital | Paris | France |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D013923 | Thromboembolism |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D011471 | Prostatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D014565 | Urogenital Neoplasms |
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| D009101 | Multiple Myeloma |
| D008232 | Lymphoproliferative Disorders |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D000078222 | Tinzaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| 6 months |
| D008206 | Lymphatic Diseases |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D009370 | Neoplasms by Histologic Type |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D001855 | Bone Marrow Diseases |
| D002241 |
| Carbohydrates |