Viscoelastic Coagulation Monitor as an Early Index of Sepsis in Patients Admitted With Infection at the Emergency Department: The VISION Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Difference in any variable captured by VCM between patients who progress or not into sepsis the first 72 hours.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults male or female (age 18 years or more)
- •Suspicion of infection, defined according to medical judgment
排除标准
- •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
结局指标
主要结局
Difference in any variable captured by VCM between patients who progress or not into sepsis the first 72 hours.
时间窗: 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.
次要结局
- 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)
研究者
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
National and Kapodistrian University of Athens