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Recruiting NCT06480994

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

— Observational Venous Thromboembolism Pulmonary Embolism Deep Vein Thrombosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Routine Assays on fresh plasma, New Clinical Decision Support on fresh plasma, New Clinical Decision Support on frozen plasma.
Who it may be relevant to
Registry conditions: Venous Thromboembolism, Pulmonary Embolism, Deep Vein Thrombosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Diagnostic test 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
  • Diagnostic test 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.
  • Diagnostic test 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.

Primary outcome measures

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

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 4 centers
  • Centre Hospitalier de Niort — Niort
  • Centre Hospitalier le Mans — Le Mans
  • CHU Dijon Bourgogne — Dijon
  • University Hospital Grenoble — Grenoble

Publications

  • 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

Identifiers

NCT: NCT06480994 · EXTEND 2021-A03135-36

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗