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

NCT06480994 | Recruiting

• 1 other identifier: EXTEND 2021-A03135-36
• Study Type: observational
• Target: 1,836
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Venous Thromboembolism; Pulmonary Embolism; Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (7)

• 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.

  48 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Diagnostica Stago R&D: lead
• Centre Hospitalier de Niort: collaborator
• Centre Hospitalier le Mans: collaborator
• Centre Hospitalier Universitaire Dijon: collaborator
• University Hospital, Grenoble: collaborator

Study Sites (4)

Centre Hospitalier de Niort

Niort, Sartres, 79021, France

RECRUITING

Centre Hospitalier le Mans

Le Mans, Sartre, 72037, France

RECRUITING

CHU Dijon Bourgogne

Dijon, France

RECRUITING

University Hospital Grenoble

Grenoble, France

RECRUITING

Related Publications (31)

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  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen plasma aliquots collected on citrated tubes

MeSH Terms

Conditions

Venous Thromboembolism; Pulmonary Embolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Thrombosis

Study Officials

• VINCENT VIOLEAU

  Centre Hospitalier de Niort

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AURELIE LAMIELLE

CONTACT

0141471500; aurelie.lamielle@stago.com

OLIVIER MATHIEU

CONTACT

0141471500; olivier.mathieu@stago.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 1, 2024
• Study Start: June 21, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)