Health TrialsbyHealthPanel

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

ConditionsVenous ThromboembolismPulmonary EmbolismDeep Vein Thrombosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDiagnostica Stago R&D

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Preventive or curative anticoagulant treatment, or fibrinolytic treatment,

Legal protection (e.g. guardianship or curatorship),

Pregnant or breastfeeding women.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Routine Assays on fresh plasma

    Diagnostic test

    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

    Diagnostic test

    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

    Diagnostic test

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Reproducibility of the new clinical decision support with fresh plasma

Reproducibility (%) calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.

Time frame
37 months
2

Threshold of the new clinical decision support with fresh plasma

Threshold calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.

Time frame
37 months
3

PE / DVT sensitivity of the clinical decision support

Sensitivity of the clinical decision support with fresh plasma in comparison with reference diagnosis.

Time frame
48 months
4

PE / DVT specificity of the clinical decision support

Specificity of the clinical decision support with fresh plasma in comparison with reference diagnosis.

Time frame
48 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Diagnostica Stago R&D

Lead sponsor

Centre Hospitalier de Niort

Collaborator

Centre Hospitalier le Mans

Collaborator

Centre Hospitalier Universitaire Dijon

Collaborator

University Hospital, Grenoble

Collaborator

Source ClinicalTrials.gov
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