Life sciences · Observational Study
ClinicalTrials.gov · September 21, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07073456). This is a study registration, not published results. Lead sponsor: Hellenic Institute for the Study of Sepsis. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 147 participants (ACTUAL). Conditions: Infection, Sepsis. Interventions: DIAGNOSTIC_TEST: Viscoelastic Coagulation Monitoring measurements. Primary outcome measures: Difference in any variable captured by VCM between patients who progress or not into sepsis the first 72 hours. , From enrollment to 72-hour follow-up period. Brief summary: 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.