Evaluating a new decision support tool for diagnosing blood clots
Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support With Fresh Plasma, on Any Patient With VTE Suspicion
Diagnostica Stago R&D · NCT06480994
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 |
|---|---|
| Enrollment | 1836 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Diagnostica Stago R&D (industry) |
| Locations | 4 sites (Niort, Sartres and 3 other locations) |
| Trial ID | NCT06480994 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with suspected pulmonary embolism or deep vein thrombosis who are eligible for D-dimer assays.
Not a fit: Patients currently receiving anticoagulant or fibrinolytic treatment, or those under legal protection, may not benefit from this study.
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 performed: While there have been studies on diagnostic tools for VTE, this specific approach comparing fresh and frozen plasma is relatively novel.
Eligibility criteria
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 this trial is running
Niort, Sartres and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Venous Thromboembolism, Pulmonary Embolism, Deep Vein Thrombosis