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

June 23, 2025 updated by: Diagnostica Stago R&D

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1836

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Dijon, France
        • Recruiting
        • Chu Dijon Bourgogne
        • Contact:
        • Principal Investigator:
          • Cindy Tissier, PhD
        • Sub-Investigator:
          • Emmanuel De Maistre, PhD
      • Grenoble, France
        • Recruiting
        • University Hospital Grenoble
        • Contact:
        • Principal Investigator:
          • Damien Viglino, PhD
        • Sub-Investigator:
          • Raphael Marlu, PhD
    • Sartre
      • Le Mans, Sartre, France, 72037
        • Recruiting
        • Centre Hospitalier Le Mans
        • Contact:
        • Principal Investigator:
          • Cyrielle Houalard, PhD
        • Sub-Investigator:
          • Johann Rose, PhD
    • Sartres
      • Niort, Sartres, France, 79021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study 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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
37 months
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.
37 months
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.
48 months
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.
48 months
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.
48 months
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.
48 months
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.
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diagnostica Stago R&D

Collaborators

University Hospital, Grenoble
Centre Hospitalier le Mans
Centre Hospitalier de Niort
CHU Dijon Bourgogne

Investigators

  • Principal Investigator: VINCENT VIOLEAU, Centre Hospitalier de Niort

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2022

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXTEND 2021-A03135-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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