Clinical trial NCT06480994: Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support
Official title: Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support With Fresh Plasma, on Any Patient With VTE Suspicion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Venous Thromboembolism
Pulmonary Embolism
Deep Vein Thrombosis
Lead sponsor: Diagnostica Stago R&D
Sponsor class: INDUSTRY
Collaborators: name: Centre Hospitalier de Niort
name: Centre Hospitalier le Mans
First posted: 2024-07-01
Enrollment: 1836
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * 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

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.

Detailed description: 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.

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.

Primary outcomes:
measure: Reproducibility of the new clinical decision support with fresh plasma
timeFrame: 37 months
measure: Threshold of the new clinical decision support with fresh plasma
timeFrame: 37 months
measure: PE / DVT sensitivity of the clinical decision support
timeFrame: 48 months
measure: PE / DVT specificity of the clinical decision support
timeFrame: 48 months
measure: PE / DVT likelihood ratio of the clinical decision support
timeFrame: 48 months
measure: PE / DVT exclusion percentage of the clinical decision support
timeFrame: 48 months
measure: PE / DVT negative predictive value of the clinical decision support
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Niort
country: France
facility: Centre Hospitalier de Niort
state: Sartres
city: Le Mans
country: France
facility: Centre Hospitalier le Mans
state: Sartre
Study officials:
affiliation: Centre Hospitalier de Niort
name: VINCENT VIOLEAU
role: PRINCIPAL_INVESTIGATOR
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