Viscoelastic Coagulation for Early Sepsis Detection

NCT07073456 | Recruiting

• 1 other identifier: 10th/09-10-2024
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Sepsis

Keywords

blood coagulation; infection; sepsis; clot formation; Viscoelastic Coagulation Monitor; early sepsis detection

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to 72-hour follow-up period

Secondary Outcomes (3)

• 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

• Correlation between the eight VCM variables and the coagulation variables.

  From enrollment to 72-hour-follow-up period

• Correlation between the eight VCM variables and the measured inflammatory mediators

  From enrollment to 72-hour-follow up period

Study Arms (1)

Patients with suspicion of infection, defined according to medical judgment

Diagnostic Test: Viscoelastic Coagulation Monitoring measurements

Interventions

Viscoelastic Coagulation Monitoring measurements DIAGNOSTIC_TEST

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.

Patients with suspicion of infection, defined according to medical judgment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Institute for the Study of Sepsis: lead

Study Sites (1)

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

Chaïdári, Attica, 12462, Greece

RECRUITING

MeSH Terms

Conditions

Infections; Sepsis; Thrombosis

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Evangelos J. Giamarellos-Bourboulis, MD, PhD

CONTACT

00302105831994; egiamarel@med.uoa.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine and Infectious Diseases, 4th Department of Internal Medicine, NKUA, President of the European Sepsis Alliance, President of the Hellenic Institute for the Study of Sepsis, President of the Hellenic Society for Chemotherapy

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: October 31, 2024
• Primary Completion: October 31, 2025
• Study Completion: November 25, 2025
• Last Updated: July 23, 2025

Record last verified: 2024-10

Locations

GR (1)