Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-31 @ 8:54 PM
Study NCT ID:
NCT07073456
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Viscoelastic Coagulation for Early Sepsis Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2025-07-09', 'studyFirstSubmitQcDate': '2025-07-09', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in any variable captured by VCM between patients who progress or not into sepsis the first 72 hours.', 'timeFrame': 'From enrollment to 72-hour follow-up period', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Difference in any variable captured by VCM between patients who progress or not into any major embolic event the first 72 hours', 'timeFrame': 'From enrollment to 72-hour-follow up period', 'description': 'Difference in any variable captured by VCM between patients who progress or not into any major embolic event the first 72 hours.'}, {'measure': 'Correlation between the eight VCM variables and the coagulation variables.', 'timeFrame': 'From enrollment to 72-hour-follow-up period', 'description': "Assessment of the correlation between eight viscoelastic parameters measured using the VCM® device and standard laboratory coagulation markers.\n\nThe 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).\n\nThese will be correlated with the following coagulation variables:\n\nAbsolute platelet count, International Normalized Ratio (INR), Activated Partial Thromboplastin Time (aPTT), D-dimers, Fibrinogen concentration.\n\nINR, aPTT, fibrinogen, and D-dimers will be measured using the SIEMENS coagulation panel. Correlation analysis will be performed using Spearman's rank correlation coefficient."}, {'measure': 'Correlation between the eight VCM variables and the measured inflammatory mediators', 'timeFrame': 'From enrollment to 72-hour-follow up period', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['blood coagulation', 'infection', 'sepsis', 'clot formation', 'Viscoelastic Coagulation Monitor', 'early sepsis detection'], 'conditions': ['Infection', 'Sepsis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults male or female (age 18 years or more)\n* Suspicion of infection, defined according to medical judgment\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Denial for consent\n* Intake of any anti-coagulant medication the last one month\n* Intake of any anti-platelet medication the last one month\n* Intake of any biological disease modifying anti-rheumatic medication the last one month\n* Medical history of inflammatory bowel disease or pulmonary hypertension\n* Any medical history of hemophilia or congenital coagulation disorders\n* Any known solid tumor or hematologic malignancy irrespective the stage and treatment\n* Known infection by the hepatitis viruses B and C\n* Known infection by the human immunodeficiency virus\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT07073456', 'acronym': 'VISION', 'briefTitle': 'Viscoelastic Coagulation for Early Sepsis Detection', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Institute for the Study of Sepsis'}, 'officialTitle': 'Viscoelastic Coagulation Monitor as an Early Index of Sepsis in Patients Admitted With Infection at the Emergency Department: The VISION Project', 'orgStudyIdInfo': {'id': '10th/09-10-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with suspicion of infection, defined according to medical judgment', 'interventionNames': ['Diagnostic Test: Viscoelastic Coagulation Monitoring measurements']}], 'interventions': [{'name': 'Viscoelastic Coagulation Monitoring measurements', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Patients with suspicion of infection, defined according to medical judgment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12462', 'city': 'Chaïdári', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Evangelos J. Giamarellos-Bourboulis, MD, PhD', 'role': 'CONTACT', 'email': 'egiamarel@med.uoa.gr', 'phone': '00302105831994'}], 'facility': 'ED & 4th Department of Internal Medicine, "Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School', 'geoPoint': {'lat': 38.01135, 'lon': 23.66597}}], 'centralContacts': [{'name': 'Evangelos J. Giamarellos-Bourboulis, MD, PhD', 'role': 'CONTACT', 'email': 'egiamarel@med.uoa.gr', 'phone': '00302105831994'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Institute for the Study of Sepsis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': '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', 'investigatorFullName': 'Evangelos Giamarellos-Bourboulis', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}