Evaluation of Performances of Soluble Fibrin Assay in Exclusion of Pulmonary Embolism and Deep Venous Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 863
- 试验地点
- 1
- 主要终点
- Performances of the Soluble Fibrin Assay for the exclusion of PE and DVT
研究概览
简要总结
The purpose of the study is to evaluate the performances of Soluble Fibrin assay for exclusion of Pulmonary Embolism and Deep Venous Thrombosis. Secondary objectives are to determine the threshold value from the ROC curves, the possible interest in the positive diagnosis of Venous Thromboembolism (VTE), and to verify the absence of influence of age on the SF results.
详细描述
Rationale. Pulmonary embolism (PE) is a major public health problem. D-dimer (D-Di) assay is useful to exclude VTE (DVT and 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 evaluate the performances of Soluble Fibrin assay in terms of sensitivity, specificity, negative and positive predictive values for exclusion of Pulmonary Embolism and Deep Venous Thrombosis, in comparison with the D-Dimer test. To determine the threshold value from the ROC curves.
Patients. Inclusion criteria: patients 18 years or older, referred to the Emergency or Internal Medicine Units, for clinically suspected of PE or DVT.
The study was conducted in compliance with French regulation after ethics approval, the authorization for processing personal data (Commission Nationale de l'Informatique et des Libertés, 8, rue Vivienne CS 30223 75083 Paris Cedex 02) decision DR-2015-174 was obtained in April 2015. A preliminary study was performed from April 2015 to September 2015 to define the exclusion criteria.
Comparison with the D-Dimer test. Plasma D-dimer (D-Di) and soluble fibrin are measured in case of low and intermediate clinical probability.
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 with non-opposition to participate in the evaluation,
- •outpatients from Emergency or Internal Medicine Units,
- •clinically suspected of PE or DVT.
排除标准
- •patients under 18 years old,
- •patients with opposition to participate in the evaluation,
- •patients with contraindication to iodinated contrast media.
结局指标
主要结局
Performances of the Soluble Fibrin Assay for the exclusion of PE and DVT
时间窗: 24 Months
Determination of the sensitivity and specificity of the Soluble Fibrin Assay to calculate the area under the ROC curve for exclusion of PE and DVT. The most suitable threshold will be determined from the curve.
次要结局
- Threshold of the Soluble Fibrin assays for the exclusion of PE and DVT(24 Months)