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

3 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

400

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Evangelos J. Giamarellos-Bourboulis, MD, PhD
  • Telefoonnummer: 00302105831994
  • E-mail: egiamarel@med.uoa.gr

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Diagnostische toets: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Differences in VCM parameters between patients who develop sepsis and those who do not
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clotting Time in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hellenic Institute for the Study of Sepsis

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 mei 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

23 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 november 2026

Eerst geplaatst (Werkelijk)

10 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

3 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • VISION II

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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