Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT02953002
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2016-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation Between The New Sepsis Scores - SOFA, Quick SOFA and Calibrated Automated Thrombogram Values
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2016-10-31', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation between sofa score and thrombin generation', 'timeFrame': 'one week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Coagulopathy']}, 'descriptionModule': {'briefSummary': 'In total 200 subjects with diagnosis of sepsis, are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). Sequential Organ Failure Assessment score SOFA will be calculated. The relation between SOFA score and thrombin measurements will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '200 men and womens diagnosed with sepsis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age above 18\n* sepsis diagnosis\n\nExclusion Criteria:\n\n* oncology patient.\n* anticoagulant treatment\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02953002', 'briefTitle': 'The Correlation Between The New Sepsis Scores - SOFA, Quick SOFA and Calibrated Automated Thrombogram Values', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'The Correlation Between The New Sepsis Scores - SOFA, Quick SOFA and Calibrated Automated Thrombogram Values', 'orgStudyIdInfo': {'id': 'EMC131-16'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Calibrated Automated Thrombogram (CAT)', 'type': 'DEVICE', 'description': 'The Calibrated Automated Thrombogram (CAT). Thrombogram describes the concentration of thrombin in clotting plasma and is therefore a general physiologic function test of the thrombotic hemostatic system. The CAT measures thrombotic as well as bleeding tendency.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'country': 'Israel', 'facility': 'Emek medical center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Elias mazen', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}