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

Diagnostica Stago

Status: Enrolling

Conditions: Pulmonary Embolism; Venous Thromboembolism; Deep Vein Thrombosis

Treatments: Diagnostic Test: New Clinical Decision Support on frozen plasma; Diagnostic Test: New Clinical Decision Support on fresh plasma; Diagnostic Test: Routine Assays on fresh plasma

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06480994

EXTEND 2021-A03135-36

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,836 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.