Explicit Assessment of Thromboembolic Risk and Prophylaxis for Medical Patients in Switzerland (ESTIMATE): Evaluation of a Prediction Rule
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,478
- 试验地点
- 4
- 主要终点
- relationship between the combined rate of fatal and non-fatal symptomatic venous thromboembolism and bleeding events and the calculated risk score at 90 days after hospital admission
研究概览
简要总结
Until now, no risk assessment model informing about the need of thromboprophylaxis in patients admitted for an acute medical event has been validated.
The goal of this project is to indirectly validate a model developed in Geneva by a non -interventional study involving the collection of patient characteristics during the hospitalization and a 3-month follow-up. These data will allow for the determination of the patient's risk, according to the Geneva model, and its validity, according the actual thrombo-embolic events, corrected for the thromboprophylaxis received.
The project is multicentric in Switzerland (5-10 centers) and should involve about 1000 patients.
First amendment (may 2011) : we have obtained the IRB approval for collecting data from patients who die during their hospital stay and for whom informed consent is not be possible to obtain.
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
- •Patients admitted (minimal stay >24 hours) to medical hospital wards
- •Age ≥18 years
- •Ability to give an informed consent, as informed by the physicians in charge of the patient
排除标准
- •Patients admitted to non-medical hospital wards
- •Patients with therapeutic anticoagulation at hospital admission
- •Patients admitted for a disease requiring therapeutic anticoagulation (MTE or other)
- •Patients unable to give an informed consent, as informed by the physicians in charge of the patient
- •Patients without signed informed consent
- •Patients already included in this study
结局指标
主要结局
relationship between the combined rate of fatal and non-fatal symptomatic venous thromboembolism and bleeding events and the calculated risk score at 90 days after hospital admission
时间窗: 90 days
evaluation of the relationship between the combined rate of fatal and non-fatal symptomatic venous thromboembolism and bleeding events at 90 days after hospital admission on one hand, and the calculated risk score provided by the Geneva Risk Assessment Models (RAM) at hospital admission on the other hand
次要结局
未报告次要终点
研究者
Mathieu R NENDAZ
MD
University Hospital, Geneva