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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,836
Routine coagulation tests using STA-R Max analyzer : Prothrombin Time (PT) activated Partial Thromboplastin Time (aPTT Thrombin Time (TT) Fibrinogen Anti-Xa activity
D-Dimer and fibrin formation assays on STA-R Max analyzer. Calculation of the exclusion score using an algorithm (manual or based on Machine Learning) compared to a Clinical Decision Support cut-off.
D-Dimer and fibrin formation assays on STA-R Max analyzer. Calculation of the exclusion score using an algorithm (manual or based on Machine Learning) compared to a Clinical Decision Support cut-off.
Centre Hospitalier de Niort
Niort, Sartres, France
RECRUITINGCentre Hospitalier le Mans
Le Mans, Sartre, France
RECRUITINGCHU Dijon Bourgogne
Dijon, France
RECRUITINGUniversity Hospital Grenoble
Grenoble, France
RECRUITINGReproducibility of the new clinical decision support with fresh plasma
Reproducibility (%) calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.
Time frame: 37 months
Threshold of the new clinical decision support with fresh plasma
Threshold calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.
Time frame: 37 months
PE / DVT sensitivity of the clinical decision support
Sensitivity of the clinical decision support with fresh plasma in comparison with reference diagnosis.
Time frame: 48 months
PE / DVT specificity of the clinical decision support
Specificity of the clinical decision support with fresh plasma in comparison with reference diagnosis.
Time frame: 48 months
PE / DVT likelihood ratio of the clinical decision support
Likelihood ratio of the clinical decision support with fresh plasma in comparison with reference diagnosis.
Time frame: 48 months
PE / DVT exclusion percentage of the clinical decision support
Exclusion percentage of the clinical decision support with fresh plasma in comparison with reference diagnosis.
Time frame: 48 months
PE / DVT negative predictive value of the clinical decision support
Negative Predictive Value of the clinical decision support with fresh plasma in comparison with reference diagnosis.
Time frame: 48 months
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