Viscoelastic Coagulation for Early Sepsis Detection

NCT ID: NCT07073456

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-11-25

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with suspicion of infection, defined according to medical judgment

Viscoelastic Coagulation Monitoring measurements

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Institute for the Study of Sepsis

OTHER

Sponsor Role: lead

Responsible Party

Evangelos Giamarellos-Bourboulis

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Chaïdári, Attica, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Evangelos J. Giamarellos-Bourboulis, MD, PhD

Role: CONTACT

egiamarel@med.uoa.gr

00302105831994

Facility Contacts

Evangelos J. Giamarellos-Bourboulis, MD, PhD

Role: primary

egiamarel@med.uoa.gr

00302105831994

Other Identifiers

10th/09-10-2024

Identifier Type: -

Identifier Source: org_study_id