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Clinical Trials in France / NCT06480994
Recruiting Observational

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

NCT06480994 · tracked via the Priya Life Science France tracker
Sponsor
Diagnostica Stago R&D
Phase
Observational
Started
2022-06-21
Last updated
2025-06-26

Condition(s) studied

Venous ThromboembolismPulmonary EmbolismDeep Vein Thrombosis

Investigational drug(s) / intervention(s)

Routine Assays on fresh plasmaNew Clinical Decision Support on fresh plasmaNew Clinical Decision Support on frozen plasma

Routine Assays on fresh plasma: Routine coagulation tests using STA-R Max analyzer : Prothrombin Time (PT) activated Partial Thromboplastin Time (aPTT Thrombin Time (TT) Fibrinogen Anti-Xa activity

New Clinical Decision Support on fresh plasma: D-Dimer and fibrin formation assays on STA-R Max analyzer. Calculation of the exclusion score using an algorithm (manual or based on Machine Learning) compared to a Clinical Decision Support cut-off.

New Clinical Decision Support on frozen plasma: D-Dimer and fibrin formation assays on STA-R Max analyzer. Calculation of the exclusion score using an algorithm (manual or based on Machine Learning) compared to a Clinical Decision Support cut-off.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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.
  • 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 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 likelihood ratio of the clinical decision support — 48 months
    Likelihood ratio 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 sites (4)

FacilityCityRegionStatus
Centre Hospitalier de Niort Niort Sartres Recruiting
Centre Hospitalier le Mans Le Mans Sartre Recruiting
CHU Dijon Bourgogne Dijon France Recruiting
University Hospital Grenoble Grenoble France Recruiting

Other trials for the same condition

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism Active, not recruiting
Duration of Therapeutic Anticoagulation in Patients With Pulmonary Embolism Recruiting
CoMbination of Data From European Cohorts as Part of the European MORPHEUS Project [HORIZON-HLTH-2022-11-01] - "MC-MORPHEUS". Recruiting
The PERSEVERE Study Recruiting
Comparison of Thrombin Generation, Platelet Activation and Aggregation Profiles in Patients With Sickle Cell Disease Depending on Their SS or SC Genotype (DrepAgreg) Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06480994 on ClinicalTrials.gov ↗ ← All trials in France