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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1836 (estimated) |
| Sponsor | Diagnostica Stago R&D Industry-sponsored |
| Locations | 4 sites (Niort, Sartres and 3 other locations) |
| Status | Recruiting |
| Started | June 21, 2022 |
| Main results expected | April 2026 |
| Study ends | February 2027 |
| Registry record updated | June 26, 2025 |
| Trial ID | NCT06480994 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
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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
- Principal investigator: Vincent Violeau — Centre Hospitalier de Niort
- Study coordinator: Aurelie Lamielle
- Email: aurelie.lamielle@stago.com
- Phone: 0141471500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.