Viscoelastic Coagulation for Early Sepsis Detection

Официальное название

Viscoelastic Coagulation Monitor as an Early Index of Sepsis in Patients Admitted With Infection at the Emergency Department: The VISION Project

Обзор

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Difference in any variable captured by VCM between patients who progress or not into sepsis the first 72 hours. [Срок оценки: From enrollment to 72-hour follow-up period]

Вторичные конечные точки (3)

• Difference in any variable captured by VCM between patients who progress or not into any major embolic event the first 72 hours [Срок оценки: From enrollment to 72-hour-follow up period]
• Correlation between the eight VCM variables and the coagulation variables. [Срок оценки: From enrollment to 72-hour-follow-up period]
• Correlation between the eight VCM variables and the measured inflammatory mediators [Срок оценки: From enrollment to 72-hour-follow up period]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Греция · 1 центр

• ED & 4th Department of Internal Medicine, "Attikon" University Hospital, National and Kapo — Chaïdári

Идентификаторы

NCT: NCT07073456 · 10th/09-10-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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