Viscoelastic Coagulation for Early Sepsis Detection

ConditionsInfectionSepsis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHellenic Institute for the Study of Sepsis

About this trial

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 criteria

Qualifiers

Adults male or female (age 18 years or more)

Suspicion of infection, defined according to medical judgment

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Viscoelastic Coagulation Monitoring measurements

Treatment groups

150 Participants
are divided into 1 treatment group

Sponsors and collaborators

Hellenic Institute for the Study of Sepsis

Lead sponsor

National and Kapodistrian University of Athens

Sponsor institution