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

NCT06480994 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1836

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

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

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.

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.

Sponsors & Collaborators

  • Centre Hospitalier de Niort

    collaborator OTHER

  • Centre Hospitalier le Mans

    collaborator OTHER

  • Centre Hospitalier Universitaire Dijon

    collaborator OTHER

  • University Hospital, Grenoble

    collaborator OTHER

  • Diagnostica Stago R&D

    lead INDUSTRY

Principal Investigators

  • VINCENT VIOLEAU · Centre Hospitalier de Niort

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2026-04-30
Completion
2027-02-28

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06480994 on ClinicalTrials.gov