Viscoelastic Coagulation for Early Sepsis Detection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Viscoelastic Coagulation Monitoring measurements.
- Who it may be relevant to
- Registry conditions: Infection, Sepsis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Viscoelastic Coagulation Monitor as an Early Index of Sepsis in Patients Admitted With Infection at the Emergency Department: The VISION Project
Overview
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.
Interventions
- Diagnostic test 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.
Primary outcome measures
- Difference in any variable captured by VCM between patients who progress or not into sepsis the first 72 hours. [Time frame: From enrollment to 72-hour follow-up period]
Secondary outcome measures (3)
- Difference in any variable captured by VCM between patients who progress or not into any major embolic event the first 72 hours [Time frame: From enrollment to 72-hour-follow up period]
- Correlation between the eight VCM variables and the coagulation variables. [Time frame: From enrollment to 72-hour-follow-up period]
- Correlation between the eight VCM variables and the measured inflammatory mediators [Time frame: From enrollment to 72-hour-follow up period]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Greece · 1 center
- ED & 4th Department of Internal Medicine, "Attikon" University Hospital, National and Kapo — Chaïdári
Identifiers
NCT: NCT07073456 · 10th/09-10-2024