About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults male or female (age 18 years or more)
Suspicion of infection, defined according to medical judgment
Disqualifiers
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
Trial population
Patients, presenting to the Emergency Department of the General Hospital of Attikon, who meet all inclusion criteria and who do not meet any exclusion criterion will be enrolled in the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Viscoelastic Coagulation Monitoring measurements
Diagnostic testPeripheral 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.
Treatment groups
Trial outcomes
Primary outcomes
Difference in any variable captured by VCM between patients who progress or not into sepsis the first 72 hours.
The study primary endpoint is the difference in any variable captured by VCM between patients who progress or not into sepsis the first 72 hours. VCM measurements of any visit can be used for this endpoint.
Secondary outcomes
Difference in any variable captured by VCM between patients who progress or not into any major embolic event the first 72 hours
Difference in any variable captured by VCM between patients who progress or not into any major embolic event the first 72 hours.
Correlation between the eight VCM variables and the coagulation variables.
Assessment of the correlation between eight viscoelastic parameters measured using the VCM® device and standard laboratory coagulation markers. The VCM parameters include: Clot Time (CT), Clot Formation Time (CFT), Alpha Angle (α), Amplitude at 10 minutes (A10), Amplitude at 20 minutes (A20), Maximum Clot Firmness (MCF), Lysis Index at 30 minutes (LI30), Lysis Index at 45 minutes (LI45). These will be correlated with the following coagulation variables: Absolute platelet count, International Normalized Ratio (INR), Activated Partial Thromboplastin Time (aPTT), D-dimers, Fibrinogen concentration. INR, aPTT, fibrinogen, and D-dimers will be measured using the SIEMENS coagulation panel. Correlation analysis will be performed using Spearman's rank correlation coefficient.
Correlation between the eight VCM variables and the measured inflammatory mediators
Assessment of the correlation between eight viscoelastic parameters measured using the VCM® device and inflammatory markers. The VCM parameters include: Clot Time (CT), Clot Formation Time (CFT), Alpha Angle (α), Amplitude at 10 minutes (A10), Amplitude at 20 minutes (A20), Maximum Clot Firmness (MCF), Lysis Index at 30 minutes (LI30), Lysis Index at 45 minutes (LI45). These will be correlated with the following inflammatory variables: tissue factor, suPAR, IL-1β, IL-6, IL-8 and TNFα.Tissue factor, suPAR, IL-1β, IL-6, IL-8 and TNFα will be measured in stored plasma samples by an enzyme immunosorbent assay. Correlation analysis will be performed using Spearman's rank correlation coefficient.
Sponsors and contacts
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Hellenic Institute for the Study of Sepsis
Lead sponsor
National and Kapodistrian University of Athens
Sponsor institution