Clinical trial Recruiting at 4 sites Observational Ages 18 and up

Evaluating a new decision support tool for diagnosing blood clots

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

Run by Diagnostica Stago R&D · NCT06480994 · Data updated 2026-11-12

This study is testing a new tool to help doctors diagnose blood clots in patients who might have conditions like pulmonary embolism or deep vein thrombosis, using fresh blood samples.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment1836 (estimated)
SponsorDiagnostica Stago R&D
Industry-sponsored
Locations4 sites (Niort, Sartres and 3 other locations)
StatusRecruiting
StartedJune 21, 2022
Main results expectedApril 2026
Study endsFebruary 2027
Registry record updatedJune 26, 2025
Trial IDNCT06480994 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with suspected pulmonary embolism or deep vein thrombosis who are eligible for D-dimer assays.

Probably not a fit

Patients currently receiving anticoagulant or fibrinolytic treatment, or those under legal protection, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the diagnostic performance of a Clinical Decision Support tool using fresh plasma samples compared to frozen plasma samples in patients suspected of having venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT). The study will analyze various patient subpopulations, including those with different clinical probabilities and specific conditions such as active cancer or COVID-19. Participants will receive standard care while their diagnostic outcomes are evaluated against established reference diagnoses.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of diagnosing venous thromboembolism, leading to better patient outcomes.

How similar studies have gone: While there have been studies on diagnostic tools for VTE, this specific approach comparing fresh and frozen plasma is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Centre Hospitalier de Niort
    Niort, Sartres, France
    Recruiting
  • Centre Hospitalier le Mans
    Le Mans, Sartre, France
    Recruiting
  • CHU Dijon Bourgogne
    Dijon, France
    Recruiting
  • University Hospital Grenoble
    Grenoble, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.