Evaluation of Performances of Soluble Fibrin Assay for Diagnosing Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Area under the ROC curve of the Soluble Fibrin for the diagnosis of PE
研究概览
简要总结
The purpose of the study is to evaluate the performances of Soluble Fibrin for diagnosing Pulmonary Embolism. Secondary objective is to compare the diagnostic performances of the Soluble Fibrin Assay and the D-Dimer test.
详细描述
Rationale. Pulmonary embolism (PE) is a major public health problem. D-dimer (D-Di) assay is useful to exclude the PE but not specific, requiring irradiating and expensive imaging tests. Preliminary results suggest that the Soluble Fibrin (SF) assay has a sensitivity comparable to the D-Di one, but a higher specificity and thus would limit the use of imaging tests.
Main objective. To compute the area under the ROC curve of the Soluble Fibrin assay for the diagnosis of PE and to assess the other diagnostic characteristics of the SF assay.
Patients. Inclusion criteria: patients 18 years or older, referred to the Emergency or Respiratory and Intensive Care Medicine Units, for clinically suspected of PE.
Exclusion criteria: pregnancy, contraindication to iodinated contrast media, anticoagulant drug at curative doses, patients with suspected PE during hospitalization and those for which the three month-follow up is impossible.
The protocol was approved by the Ethics Committee on March 2015. The study will be conducted in compliance with French regulations after ethics approval.
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 are aged 18 years or older,
- •outpatients from Emergency or Respiratory and Intensive Care Medicine Units,
- •clinically suspected of PE
排除标准
- •pregnant women,
- •patients with contraindication to iodinated contrast media,
- •patients treated with anticoagulants at curative doses,
- •patients with suspected PE during hospitalization
- •patients for which the three month-follow up is impossible.
结局指标
主要结局
Area under the ROC curve of the Soluble Fibrin for the diagnosis of PE
时间窗: 28 months
The ROC curve will be built, the area under the curve will be calculated with its confidence interval. The most suitable threshold will be determined from the curve.
次要结局
- Threshold of the Soluble Fibrin assays for the diagnosis of PE(28 months)