Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-27 @ 2:05 AM
Study NCT ID:
NCT01169168
Status:
UNKNOWN
Last Update Posted:
2010-07-26
First Post:
2010-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Fibrinogen in Patients With Systemic Inflammatory Response Syndrome (SIRS), Sepsis or Chronicle Liver Disease on Intensive Care Units (ICU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D012772', 'term': 'Shock, Septic'}], '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': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'citrated plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'lastUpdateSubmitDate': '2010-07-23', 'studyFirstSubmitDate': '2010-07-23', 'studyFirstSubmitQcDate': '2010-07-23', 'lastUpdatePostDateStruct': {'date': '2010-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibrinogen levels from 5 test methods', 'description': '* Clauss fibrinogen\n* PT-Derived fibrinogen\n* immunoturbidimetric method\n* heat-precipitated fibrinogen\n* Schulz fibrinogen'}], 'secondaryOutcomes': [{'measure': 'Number of bleedings'}, {'measure': 'Number of administered fresh frozen plasma'}, {'measure': 'Number of administered erythrocyte concentrates'}, {'measure': 'Number of administered thrombocyte concentrates'}, {'measure': 'mortality'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fibrinogen', 'SIRS', 'sepsis', 'liver disease', 'chronic liver disease', 'septic shock'], 'conditions': ['SIRS', 'Sepsis', 'Liver Disease']}, 'descriptionModule': {'briefSummary': "In this study patients with\n\n1. chronicle liver diseases\n\n * primary biliary cirrhosis\n * primary sclerosing cholangitis\n * alcoholic liver cirrhosis\n * hepatitis b or C\n * Wilson's disease\n * cryptogenic cirrhosis\n2. Septic Inflammatory Response Syndrome (SIRS)\n\n * sepsis\n * septic shock\n3. patients after lysis\n\nshould be included\n\nBlood samples will be gathered from the patients to measure fibrinogen with 5 different methods.\n\nThe methods are:\n\n* Clauss fibrinogen\n* PT-Derived fibrinogen\n* immunoturbidimetric method\n* heat-precipitated fibrinogen\n* Schulz fibrinogen\n\nThe result of these tests will be correlated with laboratory values which are gathered in routine and the clinical outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients in intensive care units of the university hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SIRS\n* sepsis\n* septic shock\n* chronicle liver disease (MELD-Score \\>10)\n* patient after lysis\n* patient agrees\n\nExclusion Criteria:\n\n* no agreement'}, 'identificationModule': {'nctId': 'NCT01169168', 'briefTitle': 'Measurement of Fibrinogen in Patients With Systemic Inflammatory Response Syndrome (SIRS), Sepsis or Chronicle Liver Disease on Intensive Care Units (ICU)', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Measurement of Fibrinogen in Patients With Systemic Inflammatory Response Syndrome, Sepsis, Chronicle Liver Disease or After Lysis on Intensive Care Units', 'orgStudyIdInfo': {'id': 'FibICU'}}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Wolfgang Miesbach', 'role': 'CONTACT', 'email': 'wolfgang.miesbach@kgu.de', 'phone': '+49696301', 'phoneExt': '7788'}, {'name': 'Alexander Ferlemann', 'role': 'CONTACT', 'email': 'ferleman@stud.uni-frankfurt.de'}, {'name': 'Wolfgang Misbach', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Carola Hecking', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexander Ferlemann', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Johann Wolfgang Goethe University Hospital', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. med. Wolfgang Miesbach', 'oldOrganization': 'Johann Wolfgang Goethe University Hospital'}}}}