Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality.
Alexander T Cohen, Giancarlo Agnelli, Frederick A Anderson...
https://pubmed.ncbi.nlm.nih.gov/17938798Actively Recruiting
Age: 18Years +
All Genders
ID06480994
Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support Using Fresh Plasma in Patients With VTE Suspicion
Led by Diagnostica Stago R&D · Updated on 2025-06-26
1836
Participants Needed
4
Research Sites
43 weeks
Total Duration
On this page
Sponsors
D
Diagnostica Stago R&D
Lead Sponsor
C
Centre Hospitalier de Niort
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research evaluates the diagnostic performance of a new Clinical Decision Support tool using fresh plasma samples in patients suspected of venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT). It compares results from fresh plasma with those from frozen plasma and the current standard diagnostic strategy. The study includes various patient groups, such as those eligible for D-dimer testing, patients with high clinical probability, patients with conditions affecting D-dimer levels, those with recent thrombotic events, active cancer, or COVID-19. The study uses routine coagulation tests and the new Clinical Decision Support algorithm on both fresh and frozen plasma samples. The algorithm applies manual or machine learning methods to calculate exclusion scores based on D-dimer and fibrin formation assays. Participants receive standard care and diagnosis according to usual practice while their plasma samples are assessed for comparison. Participants will undergo plasma sampling for routine coagulation and Clinical Decision Support testing on fresh and frozen samples. Researchers will measure outcomes including reproducibility, threshold settings, sensitivity, specificity, likelihood ratios, exclusion percentages, and negative predictive values of the Clinical Decision Support tool over periods of 37 to 48 months. The study aims to verify if fresh plasma testing can match frozen plasma performance, potentially impacting diagnostic algorithms for VTE.
CONDITIONS
Brief Title
Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Suspicion of pulmonary embolism and/or deep vein thrombosis
- Patient consents to participate and to data processing for research
- Beneficiary of social security system
- Aged 18 years or older
You will not qualify if you...
- Receiving preventive or curative anticoagulant or fibrinolytic treatment
- Under legal protection such as guardianship or curatorship
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Initial testing period
Participants undergo diagnostic testing including routine coagulation tests and clinical decision support assays on fresh and frozen plasma to assess for venous thrombo-embolism.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 48 months
Participants are observed over time to evaluate the reproducibility and diagnostic performance of the clinical decision support tool in detecting pulmonary embolism and deep vein thrombosis.
Periodic assessments during follow-up
Trial Site Locations
Total: 4 locations
1
Centre Hospitalier de Niort
Niort, Sartres, France, 79021
Actively Recruiting
2
Centre Hospitalier le Mans
Le Mans, Sartre, France, 72037
Actively Recruiting
3
CHU Dijon Bourgogne
Dijon, France
Actively Recruiting
4
University Hospital Grenoble
Grenoble, France
Actively Recruiting
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Research Team
A
AURELIE LAMIELLE
O
OLIVIER MATHIEU
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Thrombosis: a major contributor to the global disease burden.
ISTH Steering Committee for World Thrombosis Day
https://pubmed.ncbi.nlm.nih.gov/25302663Risk factors for venous thromboembolism.
Frederick A Anderson, Frederick A Spencer
https://pubmed.ncbi.nlm.nih.gov/12814980Integrated strategies for the diagnosis of venous thromboembolism.
P S Wells
https://pubmed.ncbi.nlm.nih.gov/17635707Value of assessment of pretest probability of deep-vein thrombosis in clinical management.
P S Wells, D R Anderson, J Bormanis...
https://pubmed.ncbi.nlm.nih.gov/9428249Prediction of pulmonary embolism in the emergency department: the revised Geneva score.
Grégoire Le Gal, Marc Righini, Pierre-Marie Roy...
https://pubmed.ncbi.nlm.nih.gov/16461960Venous thromboembolism: Past, present and future.
Sam Schulman, Walter Ageno, Stavros V Konstantinides
https://pubmed.ncbi.nlm.nih.gov/28594049Diagnostic accuracy of D-dimer test for exclusion of venous thromboembolism: a systematic review.
M Di Nisio, A Squizzato, A W S Rutjes...
https://pubmed.ncbi.nlm.nih.gov/17155963Is it worth diagnosing and treating distal deep vein thrombosis? No.
M Righini
https://pubmed.ncbi.nlm.nih.gov/17635709Inflammation, ageing and chronic disease.
Graham Pawelec, David Goldeck, Evelyna Derhovanessian
https://pubmed.ncbi.nlm.nih.gov/24762450