Venous Thromboembolism
Conditions
Keywords
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
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
Interventions
DRUGTinzaparin
Subcutaneous injection of 175 IU/kg once daily for 6 months
Sponsors
LEO Pharma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Venous thromboembolism recurrence | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major hemorrhage | 6 months | — |
| Death | 6 months | All cause mortality |
| Heparin induced thrombocytopenia | 6 months | — |
Other
| Measure | Time frame |
|---|---|
| Premature treatment discontinuation | 6 months |
Countries
France
Outcome results
None listed