Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support
Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support With Fresh Plasma, on Any Patient With VTE Suspicion
Diagnostica Stago R&D
1,836 participants
Jun 21, 2022
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria3
- Preventive or curative anticoagulant treatment, or fibrinolytic treatment,
- Legal protection (e.g. guardianship or curatorship),
- Pregnant or breastfeeding women.
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Interventions
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.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06480994