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Viscoelastic Coagulation for Early Sepsis Detection

Study acronym: VISION
StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Minor Trial completed Show 5 more changesShow less
    • Study completion date changed from estimate of Nov 25, 2025 to Oct 25, 2025
    • Enrollment target: estimated 150 to confirmed 147
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Minor Secondary endpoints: details revised at 2 of 3 entries
    • Study title shortened, about 1 word
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07073456
Lead Sponsor Hellenic Institute for the Study of Sepsis
Conditions
(from sponsor)
Infection, Sepsis
Related terms Infections, Sepsis, Thrombosis
Enrollment 147 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov