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RECRUITING
NCT07073456

Viscoelastic Coagulation for Early Sepsis Detection

Sponsor: Hellenic Institute for the Study of Sepsis

View on ClinicalTrials.gov

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.

Official title: Viscoelastic Coagulation Monitor as an Early Index of Sepsis in Patients Admitted With Infection at the Emergency Department: The VISION Project

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2024-10-31

Completion Date

2025-11-25

Last Updated

2025-07-23

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

Viscoelastic Coagulation Monitoring measurements

Peripheral venous blood samples will be obtained for the assessment of the eight following parameters utilizing the VCM (Viscoelastic Coagulation Monitor) device: clot time, clot formation time, alpha angle, amplitude at 10 minutes, amplitude at 20 minutes, maximum clot formation, lysis index at 30 minutes, and lysis index at 45 minutes. These parameters will be measured at the Emergency Department and subsequently on a daily basis for three consecutive days, if the patient is hospitalised.

Locations (1)

ED & 4th Department of Internal Medicine, "Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School

Chaïdári, Attica, Greece