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Completed

NCT Number: NCT07073456

Viscoelastic Coagulation for Early Sepsis Detection

The goal of this observational study is to investigate whether selected variables of coagulation measured by Viscoelastic Coagulation Monitoring (VCM) can serve as early predictors of progression to sepsis in adult patients presenting to the emergency department (ED) with suspected infection. The main questions it aims to answer are: Can any of the eight VCM-derived coagulation parameters predict early progression into sepsis? Is there a specific VCM profile associated with higher sepsis risk at ED presentation? Participants presenting to the Emergency Department with signs of suspected infection will be asked to provide written informed consent, either personally or via a legal representative. Upon consent, they will be enrolled in the study. All participants will undergo at the Emergency Department blood sampling for VCM analysis, for complete blood count, routine biochemical tests and inflammatory markers (e.g., CRP and procalcitonin). In case of discharge, patients will be contacted by phone for three consecutive days to monitor the course of infection and assess survival status. In case of admission, blood for VCM analysis will be collected daily for three consecutive days. This is a single-center, prospective proof-of-concept study conducted at ATTIKON University General Hospital in collaboration with the 4th Department of Internal Medicine.

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Key information

Conditions

Infection Cardiovascular Diseases Embolism and Thrombosis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

4th Department of Internal Medicine, "Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School, Chaïdári, Attica, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults male or female (age 18 years or more)
  • Suspicion of infection, defined according to medical judgment

Exclusion criteria

  • Age less than 18 years
  • Denial for consent
  • Intake of any anti-coagulant medication the last one month
  • Intake of any anti-platelet medication the last one month
  • Intake of any biological disease modifying anti-rheumatic medication the last one month
  • Medical history of inflammatory bowel disease or pulmonary hypertension
  • Any medical history of hemophilia or congenital coagulation disorders
  • Any known solid tumor or hematologic malignancy irrespective the stage and treatment
  • Known infection by the hepatitis viruses B and C
  • Known infection by the human immunodeficiency virus
  • Pregnancy or lactation

Treatment and study plan

Viscoelastic Coagulation Monitoring measurements

Diagnostic Test

Peripheral venous blood samples will be obtained for the assessment of the eight following parameters utilizing the VCM (Viscoelastic Coagulation Monitor) device: clot time, clot formation time, alpha angle, amplitude at 10 minutes, amplitude at 20 minutes, maximum clot formation, lysis index at 30 minutes, and lysis index at 45 minutes. These parameters will be measured at the Emergency Department and subsequently on a daily basis for three consecutive days, if the patient is hospitalised.

Primary outcomes

  1. Difference in any variable captured by VCM between patients who progress or not into sepsis the first 72 hours.

    Time frame: From enrollment to 72-hour follow-up period

    The study primary endpoint is the difference in any variable captured by VCM between patients who progress or not into sepsis the first 72 hours. VCM measurements of any visit can be used for this endpoint.

Secondary outcomes

  1. Difference in any variable captured by VCM between patients who progress or not into any major embolic event the first 72 hours

    Time frame: From enrollment to 72-hour-follow up period

    Difference in any variable captured by VCM between patients who progress or not into any major embolic event the first 72 hours.

  2. Correlation between the eight VCM variables and the coagulation variables.

    Time frame: From enrollment to 72-hour-follow-up period

    Assessment of the correlation between eight viscoelastic parameters measured using the VCM® device and standard laboratory coagulation markers.

    The VCM parameters include: Clot Time (CT), Clot Formation Time (CFT), Alpha Angle (α), Amplitude at 10 minutes (A10), Amplitude at 20 minutes (A20), Maximum Clot Firmness (MCF), Lysis Index at 30 minutes (LI30), Lysis Index at 45 minutes (LI45).

    These will be correlated with the following coagulation variables:

    Absolute platelet count, International Normalized Ratio (INR), Activated Partial Thromboplastin Time (aPTT), D-dimers, Fibrinogen concentration.

    INR, aPTT, fibrinogen, and D-dimers will be measured using the SIEMENS coagulation panel. Correlation analysis will be performed using Spearman's rank correlation coefficient.

  3. Correlation between the eight VCM variables and the measured inflammatory mediators

    Time frame: From enrollment to 72-hour-follow up period

    Assessment of the correlation between eight viscoelastic parameters measured using the VCM® device and inflammatory markers. The VCM parameters include: Clot Time (CT), Clot Formation Time (CFT), Alpha Angle (α), Amplitude at 10 minutes (A10), Amplitude at 20 minutes (A20), Maximum Clot Firmness (MCF), Lysis Index at 30 minutes (LI30), Lysis Index at 45 minutes (LI45). These will be correlated with the following inflammatory variables: tissue factor, suPAR, IL-1β, IL-6, IL-8 and TNFα.Tissue factor, suPAR, IL-1β, IL-6, IL-8 and TNFα will be measured in stored plasma samples by an enzyme immunosorbent assay. Correlation analysis will be performed using Spearman's rank correlation coefficient.

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Sponsors and collaborators

Lead sponsor

Hellenic Institute for the Study of Sepsis

Other

Registry information

Official study title

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

Acronym: VISION

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2025
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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