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

Recruiting

• Conditions: Venous Thromboembolism; Pulmonary Embolism; Deep Vein Thrombosis

• Registration Number: NCT06480994
• Lead Sponsor: Diagnostica Stago R&D

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.

Study Timeline

• Study Start: 2022-06-21
• Status Verified: 2024-06
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Study First Posted: 2024-07-01
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-11
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1836

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Threshold of the new clinical decision support with fresh plasma	37 months	Threshold calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.
PE / DVT likelihood ratio of the clinical decision support	48 months	Likelihood ratio of the clinical decision support with fresh plasma in comparison with reference diagnosis.
Reproducibility of the new clinical decision support with fresh plasma	37 months	Reproducibility (%) calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.
PE / DVT sensitivity of the clinical decision support	48 months	Sensitivity of the clinical decision support with fresh plasma in comparison with reference diagnosis.
PE / DVT specificity of the clinical decision support	48 months	Specificity of the clinical decision support with fresh plasma in comparison with reference diagnosis.
PE / DVT exclusion percentage of the clinical decision support	48 months	Exclusion percentage of the clinical decision support with fresh plasma in comparison with reference diagnosis.
PE / DVT negative predictive value of the clinical decision support	48 months	Negative Predictive Value of the clinical decision support with fresh plasma in comparison with reference diagnosis.

Trial Locations

Locations (2)

Centre Hospitalier de Niort; 🇫🇷 Niort, Sartres, France

Centre Hospitalier le Mans; 🇫🇷 Le Mans, Sartre, France