Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support With Fresh Plasma, on Any Patient With VTE Suspicion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,836
- 试验地点
- 4
- 主要终点
- Reproducibility of the new clinical decision support with fresh plasma
研究概览
简要总结
The goal of this non interventional study is to demonstrate the diagnostic performances on fresh plasmas in comparison with the performances on frozen plasmas in any patients with VTE suspicion, whatever the pre-test probability. The main question it aims to answer is :
Are the performances equivalent on fresh plasmas in comparison with frozen plasmas or is it necessary to determine a new algorithm of the Clinical Decision Support with a new cut-off? Participants will be diagnosed and treated in accordance with routine standard of care.
详细描述
Establish the diagnostic performance of the Clinical Decision Support tool on fresh plasma, in PE and in DVT, in comparison with that on frozen plasma, and in comparison with the current diagnostic strategy, on the entire population and on the following different subpopulations:
- Patients eligible for D-dimer assay, with low or moderate clinical probability, compared to the reference diagnosis (imaging and D-Dimer adjusted and not adjusted for age)
- Patients with high clinical probability, compared to the reference diagnosis (imaging)
- Patients not eligible for D-dimer assay: either with a condition associated with increased D-dimer levels in the absence of VTE, or with a history of PE or DVT for less than 3 months or suspected thrombotic events
- Patients with known and active cancer
- Patients with COVID-19. The assays will be conducted on a fresh and frozen plasma aliquots.
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
- •PE and/or DVT suspicion
- •No opposition after informing the patient for his participation in research and processing of their data for this purpose,
- •Benefiting from the social security system
排除标准
- •Preventive or curative anticoagulant treatment, or fibrinolytic treatment,
- •Legal protection (e.g. guardianship or curatorship),
- •Pregnant or breastfeeding women.
结局指标
主要结局
Reproducibility of the new clinical decision support with fresh plasma
时间窗: 37 months
Reproducibility (%) calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.
Threshold of the new clinical decision support with fresh plasma
时间窗: 37 months
Threshold calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.
PE / DVT likelihood ratio of the clinical decision support
时间窗: 48 months
Likelihood ratio of the clinical decision support with fresh plasma in comparison with reference diagnosis.
PE / DVT sensitivity of the clinical decision support
时间窗: 48 months
Sensitivity of the clinical decision support with fresh plasma in comparison with reference diagnosis.
PE / DVT specificity of the clinical decision support
时间窗: 48 months
Specificity of the clinical decision support with fresh plasma in comparison with reference diagnosis.
PE / DVT exclusion percentage of the clinical decision support
时间窗: 48 months
Exclusion percentage of the clinical decision support with fresh plasma in comparison with reference diagnosis.
PE / DVT negative predictive value of the clinical decision support
时间窗: 48 months
Negative Predictive Value of the clinical decision support with fresh plasma in comparison with reference diagnosis.
次要结局
未报告次要终点