Viscoelastic Coagulation for Early Sepsis Detection

Recruiting

• Conditions: Infection; Sepsis

• Registration Number: NCT07073456
• Lead Sponsor: Hellenic Institute for the Study of Sepsis

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-31
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Submitted: 2025-07-18
• Last Update Posted: 2025-07-23
• Primary Completion: 2025-10-31
• Study Completion: 2025-11-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adults male or female (age 18 years or more)
• Suspicion of infection, defined according to medical judgment

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Difference in any variable captured by VCM between patients who progress or not into any major embolic event the first 72 hours	From enrollment to 72-hour-follow up period	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.	From enrollment to 72-hour-follow-up period	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	From enrollment to 72-hour-follow up period	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.

Trial Locations

Locations (1)

ED & 4th Department of Internal Medicine, "Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School; 🇬🇷 Chaidari, Attiki, Greece