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

Sponsor
Diagnostica Stago R&D
Study ID
NCT06480994
Status
Recruiting
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Conditions

  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jul 1, 2024
Start date
Jun 21, 2022
Status verified
Jun 2025
Primary completion
Apr 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
1,836 participants (estimated)

Primary Outcome Measure

Reproducibility of the new clinical decision support with fresh plasma [ Time Frame: 37 months ]

Central Contacts

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