Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Major bleeding and clinically relevant non major bleeding
研究概览
简要总结
Patients with cancer hospitalized for an acute medical illness have an increased risk of venous thromboembolic events. Although international guidelines suggest the use of thromboprophylaxis in these patients, the recommendations are based on studies which included a percentage of patients with cancer without primarily focusing on this high risk group.
Since patients with cancer present an increased risk of bleeding complications it is critical to evaluate the safety of thromboprophylaxis in the cancer group. Recent studies suggest a limited use of thromboprophylaxis in these patients.
The aim of this study is to evaluate the use, efficacy and safety of thromboprophylaxis in medical cancer patients hospitalized for an acute medical disease.
Design: observational, prospective study Primary end-point: incidence of major and clinically relevant non major bleeding during hospitalization Secondary endpoints: frequency of use, doses and contraindications for pharmacological thromboprophylaxis; venous thromboembolic events up to three months after discharge
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
- •all patients with cancer hospitalized for an acute medical illness
排除标准
- •current use of oral or parenteral anticoagulant treatment
- •no informed consent to participate
结局指标
主要结局
Major bleeding and clinically relevant non major bleeding
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 week
次要结局
- Minor bleeding(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Venous thromboembolism(Participants will be followed up to 3 months after discharge, an expected average of 13 weeks)
研究者
Marcello Di Nisio
Principal Investigator
G. d'Annunzio University
