An observational study in Sepsis, Infection and Sepsis-Induced Coagulopathy, sponsored by Hellenic Institute for the Study of Sepsis. Not yet recruiting at 9 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Hellenic Institute for the Study of Sepsis · Observational
The VISION II study is a prospective, multicenter, observational cohort study evaluating the diagnostic performance of Viscoelastic Coagulation Monitor (VCM) parameters for the early identification of sepsis in adults presenting to the Emergency Department with suspected infection.The previous single-center, proof-of-concept VISION study (NCT07073456) showed that shorter clotting time (CT) was independently associated with sepsis and that patients with sepsis accumulated a greater number of out-of-range VCM measurements during follow-up. Although CT demonstrated potential for distinguishing between patients with and without sepsis, its diagnostic performance was moderate, supporting further evaluation in a larger, multicenter cohort.
Sepsis is frequently associated with hemostatic disturbances resulting from the close interaction between inflammation and coagulation. These alterations may occur early in the course of infection but may not be adequately detected by conventional coagulation tests. The Viscoelastic Coagulation Monitor (VCM) is a point-of-care device that provides a rapid bedside assessment of whole-blood clot formation and may therefore support the early identification of patients progressing to sepsis.
In the previous single-center, prospective, proof-of-concept VISION study, VCM parameters were evaluated in adults presenting to the Emergency Department with suspected infection. Shorter clotting time (CT) remained independently associated with sepsis after adjustment for established clinical scores and laboratory biomarkers. Patients with sepsis also accumulated a greater number of out-of-range VCM measurements during follow-up. However, the diagnostic performance of CT was moderate, indicating the need for validation in a larger, multicenter cohort. Moreover, patients receiving anticoagulant or antiplatelet therapy were excluded from the previous study, limiting the applicability of its findings to routine Emergency Department practice.
VISION II is a prospective, observational, multicenter study designed to evaluate the diagnostic performance of VCM parameters for the early identification of sepsis in approximately 400 adults presenting to the Emergency Department with suspected infection. Unlike the previous study, VISION II will include patients receiving chronic anticoagulant or antiplatelet therapy and will assess the potential effect of these treatments on VCM parameters and diagnostic performance.
VCM testing and clinical and laboratory assessments will be performed at enrollment and, for patients who remain hospitalized, at 24, 48, and 72 hours. Recorded assessments will include SOFA-2, qSOFA, NEWS2 scores, conventional coagulation parameters, inflammatory biomarkers, microbiological findings, administered antibiotic therapy, admission to the Intensive Care Unit, survival status, and major thromboembolic events.
The primary endpoint is the difference in VCM-derived parameters between patients who develop sepsis within the first 72 hours and those who do not. Sepsis will be defined according to the Sepsis-3 criteria. Sepsis status will be independently determined by two clinical adjudicators who will review the available clinical data from the 72-hour follow-up period while remaining blinded to the VCM results.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 400 is above the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Hellenic Institute for the Study of Sepsis is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients presenting to the Emergency Departments of participating hospitals with suspected infection who meet all inclusion criteria and none of the exclusion criteria will be enrolled in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients presenting to the Emergency Department with suspected infection, as determined by the treating physician's clinical judgment and according to the predefined infection criteria specified in the study protocol.
Diagnostic Test: Viscoelastic Coagulation Monitor (VCM) testing
Peripheral venous whole-blood samples will be collected for the assessment of eight parameters using the Viscoelastic Coagulation Monitor (VCM): clotting time (CT), clot formation time (CFT), alpha angle, amplitude at 10 minutes (A10), amplitude at 20 minutes (A20), maximum clot firmness (MCF), lysis index at 30 minutes (LI30), and lysis index at 45 minutes (LI45). Assessments will be performed at enrollment and, for patients who remain hospitalized, at 24, 48, and 72 hours. VCM results will not influence the patient's treatment or any other aspect of standard clinical care, which will remain entirely at the discretion of the treating physicians.
Differences in VCM parameters between patients who develop sepsis and those who do not
The eight VCM-derived parameters will be compared between patients who develop sepsis and those who do not. Sepsis will be defined according to the Sepsis-3 criteria as suspected or confirmed infection accompanied by an increase of ≥2 points in the Sequential Organ Failure Assessment (SOFA)-2 score or more from baseline.
Time frame: From enrollment through 72 hours
Clotting Time in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Clotting time (CT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
Time frame: From enrollment to 72 hours
Clot Formation Time in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Clot formation time (CFT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared using the Mann-Whitney U test between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
Time frame: At enrollment and at 24, 48, and 72 hours
Alpha Angle in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Alpha angle, measured in degrees using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
Time frame: At enrollment and at 24, 48, and 72 hours.
Amplitude at 10 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Amplitude at 10 minutes (A10), measured in VCM units, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
Time frame: At enrollment and at 24, 48, and 72 hours.
Maximum Clot Firmness in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Maximum clot firmness (MCF), measured in VCM units, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
Time frame: At enrollment and at 24, 48, and 72 hours.
Lysis Index at 30 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Lysis index at 30 minutes (LI30), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
Time frame: At enrollment and at 24, 48, and 72 hours.
Lysis Index at 45 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Lysis index at 45 minutes (LI45), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
Time frame: At enrollment and at 24, 48, and 72 hours.
Amplitude at 20 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
Amplitude at 20 minutes (A20), measured in VCM units, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
Time frame: At enrollment and at 24, 48, and 72 hours.
Use of chronic anticoagulant therapy or antiplatelet therapy
Number and proportion of enrolled patients receiving chronic anticoagulant therapy and those not receiving anticoagulant therapy.
Time frame: At enrollment
Clotting Time in Participants With and Without a Major Thromboembolic Event
Clotting time (CT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared between participants who develop a major thromboembolic event and participants who do not develop such an event within the first 72 hours after enrollment.
Time frame: At enrollment and at 24, 48, and 72 hours.
Clot Formation Time in Participants With and Without a Major Thromboembolic Event
Clot formation time (CFT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared between participants who develop a major thromboembolic event and participants who do not develop such an event within the first 72 hours after enrollment.
Time frame: At enrollment and at 24, 48, and 72 hours.
Alpha Angle in Participants With and Without a Major Thromboembolic Event
Alpha angle, measured in degrees using the VCM, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
Time frame: At enrollment and at 24, 48, and 72 hours.
Amplitude at 10 Minutes in Participants With and Without a Major Thromboembolic Event
Amplitude at 10 minutes (A10), measured in VCM units, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
Time frame: At enrollment and at 24, 48, and 72 hours.
Amplitude at 20 Minutes in Participants With and Without a Major Thromboembolic Event
Amplitude at 20 minutes (A20), measured in VCM units, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
Time frame: At enrollment and at 24, 48, and 72 hours.
Lysis Index at 30 Minutes in Participants With and Without a Major Thromboembolic Event
Lysis index at 30 minutes (LI30), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
Time frame: At enrollment and at 24, 48, and 72 hours.
Lysis Index at 45 Minutes in Participants With and Without a Major Thromboembolic Event
Lysis index at 45 minutes (LI45), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
Time frame: At enrollment and at 24, 48, and 72 hours.
Maximum Clot Firmness in Participants With and Without a Major Thromboembolic Event
Maximum clot firmness (MCF), measured in VCM units, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
Time frame: At enrollment and at 24, 48, and 72 hours.
Occurrence of sepsis among patients receiving chronic anticoagulant therapy
Number and proportion of patients receiving chronic anticoagulant therapy who develop sepsis, as defined by the Sepsis-3 criteria, during the study follow-up period.
Time frame: From enrollment to 72 hours
Cumulative number of out-of-range VCM parameters
The cumulative number of VCM parameters outside their predefined reference ranges will be determined at enrollment and at 24, 48, and 72 hours and compared between patients who develop sepsis and those who do not.
Time frame: At enrollment and at 24, 48, and 72 hours
Correlation between VCM parameters and inflammatory mediators
Correlations between the eight VCM-derived parameters and measured inflammatory mediators and biomarkers, including interleukin-6 (IL-6), tissue factor (CD142), procalcitonin (PCT), and C-reactive protein (CRP), will be assessed.
Time frame: At enrollment
Correlation between VCM parameters and conventional coagulation parameters
Correlations between the eight VCM-derived parameters and conventional coagulation parameters, including international normalized ratio (INR), activated partial thromboplastin time (aPTT), fibrinogen, D-dimer levels, and platelet count, will be assessed.
Time frame: At enrollment and, for hospitalized patients, at 24, 48, and 72 hours
Plan to share: No
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Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.
Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 6 months is below that.
Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Hellenic Institute for the Study of Sepsis