Viscoelastic blood-clot testing to detect sepsis early
Viscoelastic Coagulation Monitor as an Early Index of Sepsis in Patients Admitted With Infection at the Emergency Department: The VISION Project
Hellenic Institute for the Study of Sepsis · NCT07073456
We will test whether a bedside viscoelastic blood-clot test can help doctors spot early sepsis in adults who come to the emergency department with suspected infection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hellenic Institute for the Study of Sepsis (other) |
| Locations | 1 site (Chaïdári, Attica) |
| Trial ID | NCT07073456 on ClinicalTrials.gov |
What this trial studies
This is an observational study enrolling adults who present to the Emergency Department with suspected infection and give consent. Blood samples will be taken at presentation for Viscoelastic Coagulation Monitoring (VCM) to record eight coagulation parameters, plus routine labs including complete blood count, basic biochemistry, CRP and procalcitonin. Researchers will look for VCM parameter patterns at ED arrival that predict which patients go on to develop sepsis. Patients discharged from the ED will be contacted for follow-up to capture subsequent clinical progression.
Who should consider this trial
Good fit: Adults (18+) who present to the ED with suspected infection, are willing to consent, and do not have exclusions such as recent anticoagulant/antiplatelet/biologic use or known coagulation disorders will be eligible.
Not a fit: People who are pregnant or lactating, on recent anticoagulant/antiplatelet/biologic therapy, with known bleeding disorders, active viral infections (HIV, HBV, HCV), or cancer are excluded and would not be expected to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help clinicians identify patients at high risk of sepsis sooner so treatment and monitoring can start earlier to improve outcomes.
How similar studies have performed: Previous work with viscoelastic tests (like TEG/ROTEM) has shown coagulation changes in sepsis, but using VCM-derived parameters specifically as early predictors at ED presentation is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chaïdári, Attica
- ED & 4th Department of Internal Medicine, "Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School — Chaïdári, Attica, Greece (RECRUITING)
Study contacts
- Study coordinator: Evangelos J. Giamarellos-Bourboulis, MD, PhD
- Email: egiamarel@med.uoa.gr
- Phone: 00302105831994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infection, Sepsis, blood coagulation, infection, sepsis, clot formation, Viscoelastic Coagulation Monitor, early sepsis detection