Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 10:16 PM
Study NCT ID:
NCT07052656
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2025-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors and Outcomes in Patients Treated in Neurocritical Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'DAOH90', 'timeFrame': '90 days', 'description': 'Days alive and out of hospital'}, {'measure': 'Complications', 'timeFrame': '90 days', 'description': 'Rebleeding, secondary insults, cerebral infarctions'}], 'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Up to two years', 'description': 'Mortality'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': 'Up to two years', 'description': 'Neuropsychiatric diagnoses, depression/anxiety), longterm sick leave, loss of income as a proxy for quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuro-intensive Care Unit Patients', 'Subarachnoid Hemorrhage, Aneurysmal', 'Ischemic Stroke', 'Intracerebral Hemorrhage', 'Stroke, Acute', 'Meningitis', 'Epilepsy', 'Traumatic Brain Injury', 'Acute Brain Injuries', 'Acute Neurological Injury']}, 'descriptionModule': {'briefSummary': 'The overall purpose of this epidemiologic research project is to provide a comprehensive exploration and analysis of critical elements within the neuro-intensive care process in Sweden. All aspects of intensive care management in critically ill patients with acute brain injury will be addressed. The analyses include description of patient characteristics, intensive care data, management and treatments, various aspects of short and long-term follow-up, mortality, regional- and sex-related differences. The long-term goal is to develop neuro-intensive care and management, to minimize in-hospital insults and secondary injuries, to improve diagnostics and follow-up, in order to reduce prolonged neurologic deficits and mortality in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients 18 years or older treated in an ICU in Sweden with a clinical diagnosis of subarachnoid hemorrhage, intracranial hemorrhage, ischemic brain injury, traumatic brain injury, epilepsy, meningitis, encefalitis or other brain injury diagnosis from 2010 to 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU admission 2010 to 2024\n* Clinical diagnosis of subarachnoid hemorrhage, intracranial hemorrhage or ischemic brain injury, traumatic brain injury, epilepsy, meningitis, encefalititis or other brain injury diagnosis.'}, 'identificationModule': {'nctId': 'NCT07052656', 'acronym': 'EpiNIC', 'briefTitle': 'Risk Factors and Outcomes in Patients Treated in Neurocritical Care', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Risk Factors and Outcomes in Patients Treated in Neurocritical Care', 'orgStudyIdInfo': {'id': 'K2022-6426'}, 'secondaryIdInfos': [{'id': 'KI: 4-1998/2022', 'type': 'OTHER', 'domain': 'Karolinska Institutet'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neuro-intensive care patients', 'interventionNames': ['Other: Observational study, participants are not assigned an intervention as part of the study.', 'Other: Transport modality']}], 'interventions': [{'name': 'Observational study, participants are not assigned an intervention as part of the study.', 'type': 'OTHER', 'description': 'Observational study, participants are not assigned an intervention as part of the study.', 'armGroupLabels': ['Neuro-intensive care patients']}, {'name': 'Transport modality', 'type': 'OTHER', 'description': 'Transfer modality to tertiary centers', 'armGroupLabels': ['Neuro-intensive care patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Linn Hallqvist, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dep of Perioperative Medicine and Intensive care, Karolinska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Consultant, Principal Investigator', 'investigatorFullName': 'Linn Hallqvist', 'investigatorAffiliation': 'Karolinska Institutet'}}}}