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Recruiting NCT06480994

Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support

◆ AI Clinical Summary

This study tests a new clinical tool to help doctors quickly and accurately rule out blood clots (venous thromboembolism) in patients who may have them. Researchers will compare how well this tool works when using freshly collected blood samples versus frozen blood samples from patients suspected of having blood clots.

Key Objective: The trial tests whether a new diagnostic decision support tool can reliably exclude blood clots using fresh blood samples, potentially allowing faster treatment decisions.

Who to Consider: Patients with symptoms that could suggest a blood clot in their veins and who are undergoing evaluation for this condition should consider enrolling.

Trial Parameters

Condition Venous Thromboembolism
Sponsor Diagnostica Stago R&D
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,836
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-06-21
Completion 2026-04
Interventions
Routine Assays on fresh plasmaNew Clinical Decision Support on fresh plasmaNew Clinical Decision Support on frozen plasma

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * Preventive or curative anticoagulant treatment, or fibrinolytic treatment, * Legal protection (e.g. guardianship or curatorship), * Pregnant or breastfeeding women.

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