Microparticle's Procoagulant Activity to Identify Patients With Cancer and a High Risk for Venous Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 900
- 试验地点
- 7
- 主要终点
- venous thromboembolism
研究概览
简要总结
Cancer patients are at increased risk of deep venous thrombosis and pulmonary embolism, collectively termed venous thromboembolism (VTE). Risk assessment scores for VTE in cancer patients have been previously developed by the groups of Khorana and Vienna CATS. However, routine thromboprophylaxis for ambulatory cancer patients based on these scores is currently not recommended. In the investigators prospective, observational cohort study, the investigators aim to identify cancer patients at high risk for VTE based on clinical characteristics, coagulation biomarkers and the coagulant activity of tissue factor bearing microparticles.
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
- •Stage III or IV esophageal carcinoma, gastric carcinoma, intestinal carcinoma, pancreatic carcinoma, ovarian cancer, breast carcinoma, prostate cancer, urothelial cell carcinoma or lung carcinoma (small cell or non-small cell) who have started chemotherapy no more than 3 months ago
- •Chemotherapy started no more than 3 months ago or within 7 days after enrollment
- •Aged 18 years or older
- •Written informed consent
排除标准
- •Use of anticoagulants (heparin, vitamin K antagonists or direct oral anticoagulants)
- •Adjuvant chemotherapy (i.e. after surgery with curative intent)
结局指标
主要结局
venous thromboembolism
时间窗: 6 months after enrollment
Objectively confirmed asymptomatic or symptomatic deep venous thrombosis or pulmonary embolism
次要结局
- all-cause mortality(6 months after enrollment)
研究者
Harry R. Buller
Harry R Büller, MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)