Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support
NCT ID: NCT06480994
Last Updated: 2025-06-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
1836 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-06-21
Study Completion Date
2027-02-28
Brief Summary
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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.
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.
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Detailed Description
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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.
* 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.
Conditions
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Venous Thromboembolism
Pulmonary Embolism
Deep Vein Thrombosis
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
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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
Intervention Type
DIAGNOSTIC_TEST
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.
Intervention Type
DIAGNOSTIC_TEST
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.
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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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
* 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.
* Legal protection (e.g. guardianship or curatorship),
* Pregnant or breastfeeding women.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Centre Hospitalier de Niort
OTHER
Sponsor Role
collaborator
Centre Hospitalier le Mans
OTHER
Sponsor Role
collaborator
Centre Hospitalier Universitaire Dijon
OTHER
Sponsor Role
collaborator
University Hospital, Grenoble
OTHER
Sponsor Role
collaborator
Diagnostica Stago R&D
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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VINCENT VIOLEAU
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier de Niort
Locations
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Centre Hospitalier de Niort
Niort, Sartres, France
Site Status
RECRUITING
Centre Hospitalier le Mans
Le Mans, Sartre, France
Site Status
RECRUITING
CHU Dijon Bourgogne
Dijon, , France
Site Status
RECRUITING
University Hospital Grenoble
Grenoble, , France
Site Status
RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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EXTEND 2021-A03135-36
Identifier Type: -
Identifier Source: org_study_id
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