Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support

Официальное название

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

Обзор

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.

Подробное описание

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:

* Patients eligible for D-dimer assay, with low or moderate clinical probability, compared to the reference diagnosis (imaging and D-Dimer adjusted and not adjusted for age) * Patients with high clinical probability, compared to the reference diagnosis (imaging) * Patients not eligible for D-dimer assay: either with a condition associated with increased D-dimer levels in the absence of VTE, or with a history of PE or DVT for less than 3 months or suspected thrombotic events * Patients with known and active cancer * Patients with COVID-19. The assays will be conducted on a fresh and frozen plasma aliquots.

Вмешательства

• Диагностический тест Routine Assays on fresh plasma
  Routine coagulation tests using STA-R Max analyzer : Prothrombin Time (PT) activated Partial Thromboplastin Time (aPTT Thrombin Time (TT) Fibrinogen Anti-Xa activity
• Диагностический тест New Clinical Decision Support on fresh plasma
  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.
• Диагностический тест New Clinical Decision Support on frozen plasma
  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.

Первичные конечные точки

• Reproducibility of the new clinical decision support with fresh plasma [Срок оценки: 37 months]
• Threshold of the new clinical decision support with fresh plasma [Срок оценки: 37 months]
• PE / DVT sensitivity of the clinical decision support [Срок оценки: 48 months]
• PE / DVT specificity of the clinical decision support [Срок оценки: 48 months]
• PE / DVT likelihood ratio of the clinical decision support [Срок оценки: 48 months]
• PE / DVT exclusion percentage of the clinical decision support [Срок оценки: 48 months]
• PE / DVT negative predictive value of the clinical decision support [Срок оценки: 48 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Preventive or curative anticoagulant treatment, or fibrinolytic treatment,
• Legal protection (e.g. guardianship or curatorship),
• Pregnant or breastfeeding women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 4 центра

• Centre Hospitalier de Niort — Niort
• Centre Hospitalier le Mans — Le Mans
• CHU Dijon Bourgogne — Dijon
• University Hospital Grenoble — Grenoble

Публикации

• 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
• 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.
• 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
• 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. PMID 17938798
• ISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to the global disease burden. J Thromb Haemost. 2014 Oct;12(10):1580-90. doi: 10.1111/jth.12698. PMID 25302663
• Anderson FA Jr, Spencer FA. Risk factors for venous thromboembolism. Circulation. 2003 Jun 17;107(23 Suppl 1):I9-16. doi: 10.1161/01.CIR.0000078469.07362.E6. PMID 12814980
• Wells PS. Integrated strategies for the diagnosis of venous thromboembolism. J Thromb Haemost. 2007 Jul;5 Suppl 1:41-50. doi: 10.1111/j.1538-7836.2007.02493.x. PMID 17635707
• Wells PS, Anderson DR, Bormanis J, Guy F, Mitchell M, Gray L, Clement C, Robinson KS, Lewandowski B. Value of assessment of pretest probability of deep-vein thrombosis in clinical management. Lancet. 1997 Dec 20-27;350(9094):1795-8. doi: 10.1016/S0140-6736(97)08140-3. PMID 9428249

Идентификаторы

NCT: NCT06480994 · EXTEND 2021-A03135-36

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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