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| Name | Class |
|---|---|
| Centre Hospitalier de Niort | OTHER |
| Centre Hospitalier le Mans | OTHER |
| Centre Hospitalier Universitaire Dijon | OTHER |
| University Hospital, Grenoble |
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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.
Establish the diagnostic performance of the Clinical Decision Support tool on fresh plasma, in PE and in DVT, in comparison with that on frozen plasma, and in comparison with the current diagnostic strategy, on the entire population and on the following different subpopulations:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of the new clinical decision support with fresh plasma | Reproducibility (%) calculated with 70% of the study population with fresh plasma in comparison with frozen plasma. | 37 months |
| Threshold of the new clinical decision support with fresh plasma | Threshold calculated with 70% of the study population with fresh plasma in comparison with frozen plasma. | 37 months |
| PE / DVT sensitivity of the clinical decision support | Sensitivity of the clinical decision support with fresh plasma in comparison with reference diagnosis. | 48 months |
| PE / DVT specificity of the clinical decision support | Specificity of the clinical decision support with fresh plasma in comparison with reference diagnosis. | 48 months |
| PE / DVT likelihood ratio of the clinical decision support | Likelihood ratio of the clinical decision support with fresh plasma in comparison with reference diagnosis. | 48 months |
| PE / DVT exclusion percentage of the clinical decision support | Exclusion percentage of the clinical decision support with fresh plasma in comparison with reference diagnosis. | 48 months |
| PE / DVT negative predictive value of the clinical decision support | Negative Predictive Value of the clinical decision support with fresh plasma in comparison with reference diagnosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AURELIE LAMIELLE | Contact | 0141471500 | aurelie.lamielle@stago.com | |
| OLIVIER MATHIEU | Contact | 0141471500 | olivier.mathieu@stago.com |
| Name | Affiliation | Role |
|---|---|---|
| VINCENT VIOLEAU | Centre Hospitalier de Niort | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Niort | Recruiting | Niort | Sartres | 79021 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Contant G., Mirshahi S.S., Depasse F., Soria J. A new D-dimer concept for more specific detection of venous thromboembolism. Res Pract Thromb Haemost 2017; 1, (Suppl. 1), PB 1385, Abstracts of the XXVI Congress of the International Society on Thrombosis and Haemostasis, July 8-13, 2017 | ||
| Background | Planquette B, Jumel S, Pastre J, Pereira H, Marey J, Roche A, Chatellier G, Sanchez O and Meyer G. SOFIE: Soluble Fibrin for Diagnosing Pulmonary Embolism. Res Pract Thromb Haemost 2017; 1, (Suppl. 1), PB 1393, Abstracts of the XXVI Congress of the International Society on Thrombosis and Haemostasis, July 8-13, 2017. | ||
| Background | Heit JA, Cohen AT, Anderson FA. Estimated annual number of incident and recurrent, non-fatal and fatal venous thromboembolism (VTE) events in the US. Blood 2005;106(11):910 | ||
| 17938798 |
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| OTHER |
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Frozen plasma aliquots collected on citrated tubes
| 48 months |
| Centre Hospitalier le Mans | Recruiting | Le Mans | Sartre | 72037 | France |
|
| CHU Dijon Bourgogne | Recruiting | Dijon | France |
|
| University Hospital Grenoble | Recruiting | Grenoble | France |
|
| Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG, Greer IA, Heit JA, Hutchinson JL, Kakkar AK, Mottier D, Oger E, Samama MM, Spannagl M; VTE Impact Assessment Group in Europe (VITAE). Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007 Oct;98(4):756-64. doi: 10.1160/TH07-03-0212. |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D011655 | Pulmonary Embolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D013927 | Thrombosis |
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