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Viscoelastic Coagulation for Early Sepsis Detection

Viscoelastic Coagulation for Early Sepsis Detection

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Infection
    Sepsis

NCT07073456

Hellenic Institute for the Study of Sepsis

31 July 2025

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