Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Venous thromboembolism recurrence
研究概览
简要总结
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®)
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tinzaparin
Patients with objectively confirmed cancer associated venous thromboembolism receiving tinzaparin treatment to prevent recurrence of venous thromboembolism
干预措施: Tinzaparin (Drug)
结局指标
主要结局
Venous thromboembolism recurrence
时间窗: 6 months
次要结局
- Major hemorrhage(6 months)
- Death(6 months)
- Heparin induced thrombocytopenia(6 months)