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Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support With Fresh Plasma, on Any Patient With VTE Suspicion
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
June 21, 2022
Primary Completion Date
April 1, 2026
Completion Date
February 1, 2027
Last Updated
June 26, 2025
1,836
ESTIMATED participants
Routine Assays on fresh plasma
DIAGNOSTIC_TEST
New Clinical Decision Support on fresh plasma
DIAGNOSTIC_TEST
New Clinical Decision Support on frozen plasma
DIAGNOSTIC_TEST
Lead Sponsor
Diagnostica Stago R&D
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07015905