InfectionVISIONNCT07073456
Viscoelastic Coagulation for Early Sepsis Detection
An observational study of Infection and Sepsis, run by Hellenic Institute for the Study of Sepsis at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Viscoelastic Coagulation Monitoring measurements
- How many people
- 147 participants
- Where
- 2 sitesGreece
- Study dates
- 31 Oct 2024to 25 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, presenting to the Emergency Department of the General Hospital of Attikon, who meet all inclusion criteria and who do not meet any exclusion criterion will be enrolled in the study.
Who may be able to join
- Adults male or female (age 18 years or more)
- Suspicion of infection, defined according to medical judgment
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
4th Department of Internal Medicine, "Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School
Chaïdári, Attica, 12462
Emergency Medicine Department, Attikon University Hospital, NKUA
Chaïdári, 12462
About this study
Official title: Viscoelastic Coagulation Monitor as an Early Index of Sepsis in Patients Admitted With Infection at the Emergency Department: The VISION Project
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.
- Being tested
- Viscoelastic Coagulation Monitoring measurements
- Keywords
- blood coagulation, infection, sepsis, clot formation, Viscoelastic Coagulation Monitor, early sepsis detection
- Medical subject headings
- Infections, Sepsis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viscoelastic Coagulation Monitoring measurementsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspicion of infection, defined according to medical judgment | Not described Receives: Diagnostic Test: Viscoelastic Coagulation Monitoring measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in any variable captured by VCM between patients who progress or not into sepsis the first 72 hours.
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.
Measured: From enrollment to 72-hour follow-up period
Secondary outcomes (3)
Difference in any variable captured by VCM between patients who progress or not into any major embolic event the first 72 hours
Difference in any variable captured by VCM between patients who progress or not into any major embolic event the first 72 hours.
Measured: From enrollment to 72-hour-follow up period
Correlation between the eight VCM variables and the coagulation variables.
Assessment of the correlation between eight viscoelastic parameters measured using the VCM® device and standard laboratory coagulation markers.
The VCM parameters include: Clot Time (CT), Clot Formation Time (CFT), Alpha Angle (α), Amplitude at 10 minutes (A10), Amplitude at 20 minutes (A20), Maximum Clot Firmness (MCF), Lysis Index at 30 minutes (LI30), Lysis Index at 45 minutes (LI45).
These will be correlated with the following coagulation variables:
Absolute platelet count, International Normalized Ratio (INR), Activated Partial Thromboplastin Time (aPTT), D-dimers, Fibrinogen concentration.
INR, aPTT, fibrinogen, and D-dimers will be measured using the SIEMENS coagulation panel. Correlation analysis will be performed using Spearman's rank correlation coefficient.
Measured: From enrollment to 72-hour-follow-up period
Correlation between the eight VCM variables and the measured inflammatory mediators
Assessment of the correlation between eight viscoelastic parameters measured using the VCM® device and inflammatory markers. The VCM parameters include: Clot Time (CT), Clot Formation Time (CFT), Alpha Angle (α), Amplitude at 10 minutes (A10), Amplitude at 20 minutes (A20), Maximum Clot Firmness (MCF), Lysis Index at 30 minutes (LI30), Lysis Index at 45 minutes (LI45). These will be correlated with the following inflammatory variables: tissue factor, suPAR, IL-1β, IL-6, IL-8 and TNFα.Tissue factor, suPAR, IL-1β, IL-6, IL-8 and TNFα will be measured in stored plasma samples by an enzyme immunosorbent assay. Correlation analysis will be performed using Spearman's rank correlation coefficient.
Measured: From enrollment to 72-hour-follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start31 Oct 2024
- Primary completion25 Oct 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Institute for the Study of Sepsis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelos Giamarellos-Bourboulis, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073456
- Sponsor's protocol ID
- 10th/09-10-2024
- Acronym
- VISION
- Status last verified
- Oct 2024
- First submitted
- 9 Jul 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viscoelastic Coagulation Monitor as an Early Index of Sepsis in Patients Admitted With Infection at the Emergency Department: The VISION Project
- ClinicalTrials.gov ID
- NCT07073456
- Acronym / sponsor ID
- VISION / 10th/09-10-2024
- Keywords
- blood coagulation, infection, sepsis, clot formation, Viscoelastic Coagulation Monitor, early sepsis detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Hellenic Institute for the Study of SepsisUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 25 Oct 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspicion of infection, defined according to medical judgment | – | Diagnostic Test: Viscoelastic Coagulation Monitoring measurements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, presenting to the Emergency Department of the General Hospital of Attikon, who meet all inclusion criteria and who do not meet any exclusion criterion will be enrolled in the study.
Key inclusion criteria (2 listed)
- Adults male or female (age 18 years or more)
- Suspicion of infection, defined according to medical judgment
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viscoelastic Coagulation Monitoring measurementsPeripheral 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. | Diagnostic test | Patients with suspicion of infection, defined according to medical judgment |
Primary outcome
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
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Sepsis, run by Hellenic Institute for the Study of Sepsis at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.