Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-26 @ 7:56 AM
Study NCT ID:
NCT01463995
Status:
COMPLETED
Last Update Posted:
2018-11-29
First Post:
2011-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples (serum, plasma), cerebrovascular fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2011-10-31', 'studyFirstSubmitQcDate': '2011-11-01', 'lastUpdatePostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset', 'timeFrame': 'one year after symptom onset', 'description': 'To evaluate of the predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset'}], 'secondaryOutcomes': [{'measure': 'To evaluate of the predictive properties of clinical scores for functional outcome one year after symptom onset', 'timeFrame': 'one year after symptom onset', 'description': 'To evaluate of the predictive properties of clinical scores for functional outcome one year after symptom onset'}, {'measure': 'To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset', 'timeFrame': 'one year after symptom onset', 'description': 'To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset'}, {'measure': 'To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset', 'timeFrame': 'one year after symptom onset', 'description': 'To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset'}, {'measure': 'Transcriptome analyses', 'timeFrame': 'one year after symptom onset', 'description': 'To perform transcriptome analyses to identify new biomarkers which may predict the one year- neurological outcome'}, {'measure': 'Predictive properties of immune parameters in the cerebrovascular fluid for functional outcome one year after symptom onset', 'timeFrame': 'one year after symptom onset', 'description': 'To evaluate of the predictive properties of immune parameters in the cerebrovascular fluid for functional outcome one year after symptom onset'}, {'measure': 'Quality of life and occurence of depression in patients one year after symptom onset', 'timeFrame': 'one year after symptom onset', 'description': 'To investigate the quality of life and the occurence of depression in patients one year after symptom onset'}, {'measure': 'Quality of life and the occurence of depression and burnout syndrome in relatives', 'timeFrame': 'one year after symptom onset', 'description': 'To investigate the quality of life and the occurence of depression and burnout syndrome in relatives of patients treated on the neurological intensive care unit one year after symptom onset'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['severe neurological diseases', 'neurological intensive care unit', 'prediction', 'long-term outcome', 'biomarkers', 'prediction of long-term outcome'], 'conditions': ['Neurological Diseases']}, 'descriptionModule': {'briefSummary': 'This study examines the prognostic properties of immune parameters, clinical scores, electrophysiological tests (eeg, ssep, emg, eng) and functional imaging for the prediction of functional outcome one year after treatment on a neurological intensive care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with severe neurological diseases treated on a neurological intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe neurological disease making treatment on a neurological intensive care unit necessary\n* age ≥ 18\n* consent by the patient or the legal representative\n\nExclusion Criteria:\n\n* participation in an interventional trial'}, 'identificationModule': {'nctId': 'NCT01463995', 'acronym': 'proNICU', 'briefTitle': 'Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)', 'orgStudyIdInfo': {'id': 'proNICU cohort'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'severe neurological diseases', 'description': 'Patients with severe neurological diseases treated on the neurological intensive care unit'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Andreas Meisel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'NeuroCure Clinical Research Center, Charite, Berlin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Andreas Meisel', 'investigatorFullName': 'Andreas Meisel', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}