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

3 de novembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

400

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Evangelos J. Giamarellos-Bourboulis, MD, PhD
  • Número de telefone: 00302105831994
  • E-mail: egiamarel@med.uoa.gr

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: COHORT
  • Perspectivas de Tempo: PROSPECTIVE

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Teste de diagnostico: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Differences in VCM parameters between patients who develop sepsis and those who do not
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Clotting Time in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hellenic Institute for the Study of Sepsis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de novembro de 2026

Conclusão Primária (Estimado)

1 de maio de 2027

Conclusão do estudo (Estimado)

1 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

23 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de novembro de 2026

Primeira postagem (Real)

10 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • VISION II

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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