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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults male or female (age 18 years or more)

• Suspicion of infection, defined according to medical judgment

Locations
Other Locations
Greece
ED & 4th Department of Internal Medicine, Attikon University Hospital, National and Kapodistrian University of Athens, Medical School
RECRUITING
Chaïdári
Contact Information
Primary
Evangelos J. Giamarellos-Bourboulis, MD, PhD
egiamarel@med.uoa.gr
00302105831994
Time Frame
Start Date: 2024-10-31
Estimated Completion Date: 2025-11-25
Participants
Target number of participants: 150
Treatments
Patients with suspicion of infection, defined according to medical judgment
Related Therapeutic Areas
Sponsors
Leads: Hellenic Institute for the Study of Sepsis

This content was sourced from clinicaltrials.gov