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

Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support With Fresh Plasma, on Any Patient With VTE Suspicion

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06480994
Acronym
EXTEND
Enrollment
1836
Registered
2024-07-01
Start date
2022-06-21
Completion date
2027-02-28
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism

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.

Interventions

DIAGNOSTIC_TESTRoutine 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

DIAGNOSTIC_TESTNew 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.

DIAGNOSTIC_TESTNew 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.

Sponsors

Centre Hospitalier de Niort
CollaboratorOTHER
Centre Hospitalier le Mans
CollaboratorOTHER
Centre Hospitalier Universitaire Dijon
CollaboratorOTHER
University Hospital, Grenoble
CollaboratorOTHER
Diagnostica Stago R&D
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Reproducibility of the new clinical decision support with fresh plasma37 monthsReproducibility (%) calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.
Threshold of the new clinical decision support with fresh plasma37 monthsThreshold calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.
PE / DVT sensitivity of the clinical decision support48 monthsSensitivity of the clinical decision support with fresh plasma in comparison with reference diagnosis.
PE / DVT specificity of the clinical decision support48 monthsSpecificity of the clinical decision support with fresh plasma in comparison with reference diagnosis.
PE / DVT likelihood ratio of the clinical decision support48 monthsLikelihood ratio of the clinical decision support with fresh plasma in comparison with reference diagnosis.
PE / DVT exclusion percentage of the clinical decision support48 monthsExclusion percentage of the clinical decision support with fresh plasma in comparison with reference diagnosis.
PE / DVT negative predictive value of the clinical decision support48 monthsNegative Predictive Value of the clinical decision support with fresh plasma in comparison with reference diagnosis.

Countries

France

Contacts

Primary ContactAURELIE LAMIELLE
aurelie.lamielle@stago.com0141471500
Backup ContactOLIVIER MATHIEU
olivier.mathieu@stago.com0141471500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026