Cancer Associated Thrombosis: What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO (a Retrospective Multicenter Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Proportion of cancer patients with a venous thromboembolic event (VTE) ineligible for CARAVAGGIO study
研究概览
简要总结
Venous thromboembolism is a common and fatal disease closely related to cancer. The therapeutic challenge is major due to the high risk of recurrent thromboembolism and bleeding in patients with cancer.
Guidelines recommend the use of low molecular-weight heparin for the treatment of Cancer-Associated venous Thromboembolism (CAT) at least for 3 to 6 months of treatment.
However, recent advances through the results of several therapeutic trials such as CARAVAGGIO (NCT03045406) open the door to the use of Direct Oral AntiCoagulants (DOACs) as first-line therapy.
Nevertheless, extrapolation of its results may be limited owing to a large number of inclusion and exclusion criteria, which may have selected a reduced population.
The proportion of patients admitted with acute CAT who may not eligible to a trial as CARAVAGGIO is unknown.
详细描述
The aim of this study si to assess this proportion in a retrospective multicenter study, of patients admitted for acute Cancer-Associated venous Thromboembolism (CAT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Consecutive patients with a newly diagnosed, objectively confirmed:
- •symptomatic or unsuspected Deep Vein Thrombosis (DVT) (any location)
- •symptomatic or unsuspected Pulmonary Embolism (PE)
- •Consecutive patients with any type of cancer whose primary brain tumor or known intracerebral metastases and acute leukemia that meets at least one of the following:
- •Active cancer defined as diagnosis of cancer within six months or receiving treatment for cancer or any treatment for cancer or recurrent locally advanced or metastatic cancer.
- •Cancer diagnosed within 2 years.
排除标准
- •pregnant women or breast feeding
结局指标
主要结局
Proportion of cancer patients with a venous thromboembolic event (VTE) ineligible for CARAVAGGIO study
时间窗: Up to 6 months after venous thromboembolic event
Patient having at least one of the following exclusion criteria (from CARAVAGGIO study) : * ECOG (Eastern Cooperative Oncology Group ) Performance Status III or IV; * life expectancy of less than 6 months; * thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode; * indication for anticoagulant treatment for a disease other than the index VTE episode; * thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy; * recent brain, spinal or ophthalmic surgery * hemoglobin level lower than 8 g/dL or platelet count \<75x10\^9/L or history of heparin induced thrombocytopenia; * creatinine clearance \< 30 ml /min * acute hepatitis, chronic active hepatitis, liver cirrhosis; * uncontrolled hypertension; * concomitant use of strong inhibitors or inducers of cytochrome; * bacterial endocarditis;
次要结局
- Confirmed recurrent Venous Thromboembolic Event (VTE)(Up to 6 months after venous thromboembolic event)
- Death(Up to 6 months after venous thromboembolic event)
- Drugs used for their VTE(Up to 6 months after venous thromboembolic event)
- Bleeding event(Up to 6 months after venous thromboembolic event)