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NCT Number: NCT06480994

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

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Deep Vein Thrombosis Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier le Mans, Le Mans, Sartre, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Reproducibility of the new clinical decision support with fresh plasma

    Time frame: 37 months

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

  2. Threshold of the new clinical decision support with fresh plasma

    Time frame: 37 months

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

  3. PE / DVT sensitivity of the clinical decision support

    Time frame: 48 months

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

  4. PE / DVT specificity of the clinical decision support

    Time frame: 48 months

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

  5. PE / DVT likelihood ratio of the clinical decision support

    Time frame: 48 months

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

  6. PE / DVT exclusion percentage of the clinical decision support

    Time frame: 48 months

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

  7. PE / DVT negative predictive value of the clinical decision support

    Time frame: 48 months

    Negative Predictive Value of the clinical decision support with fresh plasma in comparison with reference diagnosis.

Study contacts

Contact information is provided by the study sponsor or research team.

AURELIE LAMIELLE

CONTACT

[email protected]

0141471500

OLIVIER MATHIEU

CONTACT

[email protected]

0141471500

Sponsors and collaborators

Lead sponsor

Diagnostica Stago R&D

Industry

Collaborators

  • Centre Hospitalier Universitaire Dijon
  • Centre Hospitalier de Niort
  • Centre Hospitalier le Mans
  • University Hospital, Grenoble

Registry information

Official study title

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

Acronym: EXTEND

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 1, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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