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Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support
Sponsor: Diagnostica Stago R&D
Summary
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.
Official title: Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support With Fresh Plasma, on Any Patient With VTE Suspicion
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1836
Start Date
2022-06-21
Completion Date
2027-02
Last Updated
2025-06-26
Healthy Volunteers
No
Interventions
Routine Assays on fresh plasma
Routine coagulation tests using STA-R Max analyzer : Prothrombin Time (PT) activated Partial Thromboplastin Time (aPTT Thrombin Time (TT) Fibrinogen Anti-Xa activity
New Clinical Decision Support on fresh plasma
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.
New Clinical Decision Support on frozen plasma
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.
Locations (4)
Centre Hospitalier de Niort
Niort, Sartres, France
Centre Hospitalier le Mans
Le Mans, Sartre, France
CHU Dijon Bourgogne
Dijon, France
University Hospital Grenoble
Grenoble, France