Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 542
- 试验地点
- 1
- 主要终点
- VTE- and bleeding incidence
研究概览
简要总结
This study aims to assess the 6- and 12-month venous thromboembolism (VTE) and bleeding incidence from the start of cancer diagnosis in a retrospective cohort of patients with esophageal cancer. Additionally, the predictive value of the Khorana score and several other VTE and bleeding prediction scores and risk factors will be evaluated.
详细描述
Patients with cancer are at high risk of venous thromboembolism (VTE), including deep-vein thrombosis and pulmonary embolism. For cancer patients receiving chemotherapy the incidence of VTE is even higher.
Several predictive models were previously developed to identify and justify thromboprophylaxis for cancer patietns who are at highest risk of VTE, like the Khorana and PROTECHT score. The Khorana score is a risk-stratification tool to select patients at high risk of VTE for thromboprophylaxis. The PROTECHT score takes cisplatin-based chemotherapy into account in addition of the Khorana score.
Thereby, the incidence of bleeding and VTE in patients with esophageal cancer is not clear.
This study aims to assess the 6- and 12-month venous thromboembolism (VTE) and bleeding incidence from the start of cancer diagnosis in a retrospective cohort of patients with esophageal cancer. Additionally, the predictive value of the Khorana score and several other VTE and bleeding prediction scores and risk factors will be evaluated.
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
- •Esophageal cancer patients
- •Receiving chemotherapy
- •Age at least 18 years old
排除标准
- •Death <3 months after cancer diagnosis (baseline)
结局指标
主要结局
VTE- and bleeding incidence
时间窗: from start of cancer diagnosis
6- and 12-month VTE- and bleeding incidence
次要结局
- Predictive performance of VTE risk factors and known prediction models(from start cancer diagnosis)
- Predictive performance of bleeding risk factors and known prediction models(from start cancer diagnosis)
- Arterial thromboembolism (ATE) incidence(from start of cancer diagnosis)
研究者
Harry R. Buller
Prof. dr. H.R. Büller, principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)