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Viscoelastic Coagulation Monitoring for Early Identification of Sepsis: The VISION II Study (VISION II)

3 novembre 2026 mis à jour par: Hellenic Institute for the Study of Sepsis

Viscoelastic Coagulation Monitor as an Early Index of Sepsis in Patients Admitted With Infection at the Emergency Department: The VISION II Study

The VISION II study is a prospective, multicenter, observational cohort study evaluating the diagnostic performance of Viscoelastic Coagulation Monitor (VCM) parameters for the early identification of sepsis in adults presenting to the Emergency Department with suspected infection.The previous single-center, proof-of-concept VISION study (NCT07073456) showed that shorter clotting time (CT) was independently associated with sepsis and that patients with sepsis accumulated a greater number of out-of-range VCM measurements during follow-up. Although CT demonstrated potential for distinguishing between patients with and without sepsis, its diagnostic performance was moderate, supporting further evaluation in a larger, multicenter cohort.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

Sepsis is frequently associated with hemostatic disturbances resulting from the close interaction between inflammation and coagulation. These alterations may occur early in the course of infection but may not be adequately detected by conventional coagulation tests. The Viscoelastic Coagulation Monitor (VCM) is a point-of-care device that provides a rapid bedside assessment of whole-blood clot formation and may therefore support the early identification of patients progressing to sepsis.

In the previous single-center, prospective, proof-of-concept VISION study, VCM parameters were evaluated in adults presenting to the Emergency Department with suspected infection. Shorter clotting time (CT) remained independently associated with sepsis after adjustment for established clinical scores and laboratory biomarkers. Patients with sepsis also accumulated a greater number of out-of-range VCM measurements during follow-up. However, the diagnostic performance of CT was moderate, indicating the need for validation in a larger, multicenter cohort. Moreover, patients receiving anticoagulant or antiplatelet therapy were excluded from the previous study, limiting the applicability of its findings to routine Emergency Department practice.

VISION II is a prospective, observational, multicenter study designed to evaluate the diagnostic performance of VCM parameters for the early identification of sepsis in approximately 400 adults presenting to the Emergency Department with suspected infection. Unlike the previous study, VISION II will include patients receiving chronic anticoagulant or antiplatelet therapy and will assess the potential effect of these treatments on VCM parameters and diagnostic performance.

VCM testing and clinical and laboratory assessments will be performed at enrollment and, for patients who remain hospitalized, at 24, 48, and 72 hours. Recorded assessments will include SOFA-2, qSOFA, NEWS2 scores, conventional coagulation parameters, inflammatory biomarkers, microbiological findings, administered antibiotic therapy, admission to the Intensive Care Unit, survival status, and major thromboembolic events.

The primary endpoint is the difference in VCM-derived parameters between patients who develop sepsis within the first 72 hours and those who do not. Sepsis will be defined according to the Sepsis-3 criteria. Sepsis status will be independently determined by two clinical adjudicators who will review the available clinical data from the 72-hour follow-up period while remaining blinded to the VCM results.

Type d'étude

Observationnel

Inscription (Estimé)

400

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Evangelos J. Giamarellos-Bourboulis, MD, PhD
  • Numéro de téléphone: 00302105831994
  • E-mail: egiamarel@med.uoa.gr

Lieux d'étude

  • Grèce
    • Attica
      • Magoula, Attica, Grèce, 19600
        • Thriasio Eleusis General Hospital, First Department of Internal Medicine
        • Contact:
        • Chercheur principal:
          • Styliani Sympardi, MD, PhD
      • Nikaia, Attica, Grèce, 18454
        • Nikaia General Hospital of Piraeus "Agios Panteleimon" - West Attica General Hospital "Agia Varvara", Emergency Department (ED)
        • Contact:
        • Chercheur principal:
          • Dimitrios Tsiftis, MD, PhD
      • Piraeus, Attica, Grèce, 18536
        • Tzaneio General Hospital of Piraeus, Emergency Department
        • Contact:
        • Chercheur principal:
          • Styliani Gerakari, MD, PhD
    • Central Macedonia
      • Exochí, Central Macedonia, Grèce, 57010
        • G. Papanikolaou Thessaloniki General Hospital, Emergency Department
        • Contact:
          • Eleni Peitsidou, MD, PhD
          • Numéro de téléphone: 00306977227355
          • E-mail: peitsidou@yahoo.gr
        • Chercheur principal:
          • Eleni Peitsidou, MD, PhD
      • Thessaloniki, Central Macedonia, Grèce, 54636
        • AHEPA Thessaloniki University General Hospital, Emergency Department
        • Contact:
          • Varvara Fyntanidou, MD, PhD
          • Numéro de téléphone: 00306977427336
          • E-mail: bfyntan@yahoo.com
        • Chercheur principal:
          • Varvara Fyntanidou, MD, PhD
    • Chaidari
      • Athens, Chaidari, Grèce, 12462
        • 4th Department of Internal Medicine, ATTIKON University General Hospital, General Hospital of West Attica H Agia Varvara, National and Kapodistrian University of Athens, Medical School
        • Contact:
        • Chercheur principal:
          • Evangelos J. Giamarellos-Bourboulis, MD, PhD
      • Athens, Chaidari, Grèce, 12462
        • Emergency Medicine Department, ATTIKON University General Hospital, General Hospital of West Attica H Agia Varvara, NKUA
        • Contact:
        • Chercheur principal:
          • Ioannis Parisis, MD, PhD
    • South Aegean
      • Ermoupoli, South Aegean, Grèce, 84100
        • Syros General Hospital "Vardakeio and Proio" Department of Internal Medicine
        • Contact:
        • Chercheur principal:
          • Georgios Giannikopoulos, MD
    • Thessaly
      • Larissa, Thessaly, Grèce, 41221
        • General Hospital of Larissa "Koutlimpaneio and Triantafylleio"
        • Contact:
          • Dimitrios Mpampalis, MD
          • Numéro de téléphone: 00306932341149
          • E-mail: dbabales@yahoo.com
        • Chercheur principal:
          • Dimitrios Mpampalis, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adult patients presenting to the Emergency Departments of participating hospitals with suspected infection who meet all inclusion criteria and none of the exclusion criteria will be enrolled in the study.

La description

Inclusion Criteria:

  • Male or female adults aged 18 years or older.
  • Written informed consent provided by the patient or, when the patient is unable to provide consent, by a legally authorized representative.
  • Suspected infection based on the predefined diagnostic criteria for infection sources specified in the study protocol and derived from published international guidelines.

Exclusion Criteria:

  • Age under 18 years.
  • Written informed consent not provided by the patient or, when applicable, by a legally authorized representative.
  • History of hemophilia or any other congenital coagulation disorder.
  • Known hematologic malignancy, regardless of disease stage.
  • Pregnancy or lactation.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Patients with suspected infection

Adult patients presenting to the Emergency Department with suspected infection, as determined by the treating physician's clinical judgment and according to the predefined infection criteria specified in the study protocol.
Test diagnostique: Viscoelastic Coagulation Monitor (VCM) testing

Peripheral venous whole-blood samples will be collected for the assessment of eight parameters using the Viscoelastic Coagulation Monitor (VCM): clotting time (CT), clot formation time (CFT), alpha angle, amplitude at 10 minutes (A10), amplitude at 20 minutes (A20), maximum clot firmness (MCF), lysis index at 30 minutes (LI30), and lysis index at 45 minutes (LI45). Assessments will be performed at enrollment and, for patients who remain hospitalized, at 24, 48, and 72 hours. VCM results will not influence the patient's treatment or any other aspect of standard clinical care, which will remain entirely at the discretion of the treating physicians.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Differences in VCM parameters between patients who develop sepsis and those who do not
Délai: From enrollment through 72 hours

The eight VCM-derived parameters will be compared between patients who develop sepsis and those who do not. Sepsis will be defined according to the Sepsis-3 criteria as suspected or confirmed infection accompanied by an increase of ≥2 points in the Sequential Organ Failure Assessment (SOFA)-2 score or more from baseline.
From enrollment through 72 hours

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Clotting Time in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Délai: From enrollment to 72 hours

Clotting time (CT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
From enrollment to 72 hours
Clot Formation Time in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Délai: At enrollment and at 24, 48, and 72 hours

Clot formation time (CFT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared using the Mann-Whitney U test between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours
Alpha Angle in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Délai: At enrollment and at 24, 48, and 72 hours.

Alpha angle, measured in degrees using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours.
Amplitude at 10 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Délai: At enrollment and at 24, 48, and 72 hours.

Amplitude at 10 minutes (A10), measured in VCM units, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours.
Maximum Clot Firmness in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Délai: At enrollment and at 24, 48, and 72 hours.

Maximum clot firmness (MCF), measured in VCM units, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours.
Lysis Index at 30 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Délai: At enrollment and at 24, 48, and 72 hours.

Lysis index at 30 minutes (LI30), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours.
Lysis Index at 45 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Délai: At enrollment and at 24, 48, and 72 hours.

Lysis index at 45 minutes (LI45), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours.
Amplitude at 20 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Délai: At enrollment and at 24, 48, and 72 hours.

Amplitude at 20 minutes (A20), measured in VCM units, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours.
Use of chronic anticoagulant therapy or antiplatelet therapy
Délai: At enrollment

Number and proportion of enrolled patients receiving chronic anticoagulant therapy and those not receiving anticoagulant therapy.
At enrollment
Clotting Time in Participants With and Without a Major Thromboembolic Event
Délai: At enrollment and at 24, 48, and 72 hours.

Clotting time (CT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared between participants who develop a major thromboembolic event and participants who do not develop such an event within the first 72 hours after enrollment.
At enrollment and at 24, 48, and 72 hours.
Clot Formation Time in Participants With and Without a Major Thromboembolic Event
Délai: At enrollment and at 24, 48, and 72 hours.

Clot formation time (CFT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared between participants who develop a major thromboembolic event and participants who do not develop such an event within the first 72 hours after enrollment.
At enrollment and at 24, 48, and 72 hours.
Alpha Angle in Participants With and Without a Major Thromboembolic Event
Délai: At enrollment and at 24, 48, and 72 hours.

Alpha angle, measured in degrees using the VCM, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
At enrollment and at 24, 48, and 72 hours.
Amplitude at 10 Minutes in Participants With and Without a Major Thromboembolic Event
Délai: At enrollment and at 24, 48, and 72 hours.

Amplitude at 10 minutes (A10), measured in VCM units, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
At enrollment and at 24, 48, and 72 hours.
Amplitude at 20 Minutes in Participants With and Without a Major Thromboembolic Event
Délai: At enrollment and at 24, 48, and 72 hours.

Amplitude at 20 minutes (A20), measured in VCM units, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
At enrollment and at 24, 48, and 72 hours.
Lysis Index at 30 Minutes in Participants With and Without a Major Thromboembolic Event
Délai: At enrollment and at 24, 48, and 72 hours.

Lysis index at 30 minutes (LI30), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
At enrollment and at 24, 48, and 72 hours.
Lysis Index at 45 Minutes in Participants With and Without a Major Thromboembolic Event
Délai: At enrollment and at 24, 48, and 72 hours.

Lysis index at 45 minutes (LI45), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
At enrollment and at 24, 48, and 72 hours.
Maximum Clot Firmness in Participants With and Without a Major Thromboembolic Event
Délai: At enrollment and at 24, 48, and 72 hours.

Maximum clot firmness (MCF), measured in VCM units, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
At enrollment and at 24, 48, and 72 hours.
Occurrence of sepsis among patients receiving chronic anticoagulant therapy
Délai: From enrollment to 72 hours

Number and proportion of patients receiving chronic anticoagulant therapy who develop sepsis, as defined by the Sepsis-3 criteria, during the study follow-up period.
From enrollment to 72 hours
Cumulative number of out-of-range VCM parameters
Délai: At enrollment and at 24, 48, and 72 hours

The cumulative number of VCM parameters outside their predefined reference ranges will be determined at enrollment and at 24, 48, and 72 hours and compared between patients who develop sepsis and those who do not.
At enrollment and at 24, 48, and 72 hours
Correlation between VCM parameters and inflammatory mediators
Délai: At enrollment

Correlations between the eight VCM-derived parameters and measured inflammatory mediators and biomarkers, including interleukin-6 (IL-6), tissue factor (CD142), procalcitonin (PCT), and C-reactive protein (CRP), will be assessed.
At enrollment
Correlation between VCM parameters and conventional coagulation parameters
Délai: At enrollment and, for hospitalized patients, at 24, 48, and 72 hours

Correlations between the eight VCM-derived parameters and conventional coagulation parameters, including international normalized ratio (INR), activated partial thromboplastin time (aPTT), fibrinogen, D-dimer levels, and platelet count, will be assessed.
At enrollment and, for hospitalized patients, at 24, 48, and 72 hours

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hellenic Institute for the Study of Sepsis

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 novembre 2026

Achèvement primaire (Estimé)

1 mai 2027

Achèvement de l'étude (Estimé)

1 mai 2027

Dates d'inscription aux études

Première soumission

23 octobre 2026

Première soumission répondant aux critères de contrôle qualité

3 novembre 2026

Première publication (Réel)

10 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • VISION II

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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