Actively Recruiting
Viscoelastic Coagulation for Early Sepsis Detection
Led by Hellenic Institute for the Study of Sepsis · Updated on 2025-07-23
150
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Viscoelastic Coagulation for Early Sepsis Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults male or female (age 18 years or more)
- Suspicion of infection, defined according to medical judgment
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
ED & 4th Department of Internal Medicine, "Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School
Chaïdári, Attica, Greece, 12462
Actively Recruiting
Research Team
E
Evangelos J. Giamarellos-Bourboulis, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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