Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-27 @ 11:53 PM
Study NCT ID:
NCT01940861
Status:
UNKNOWN
Last Update Posted:
2014-11-24
First Post:
2013-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Oxymetry in Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-21', 'studyFirstSubmitDate': '2013-09-09', 'studyFirstSubmitQcDate': '2013-09-09', 'lastUpdatePostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosage of vasopressor', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'Vasopressor for current treatment protocols for acute traumatic brain injury can lead to vasoconstriction and thus cerebral hypoperfusion that can be detected with cerebral oxymetry as a drop in SCO2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'TBI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute traumatic severe brain injury requiring neuro intensive care.\n* The patient admitted must be at least 18 years of age and under 60 years.\n* Intoxication is not an obstacle for inclusion as we believe this will not affect the recording in relation to our problem.\n\nExclusion Criteria:\n\n* Traumatic injury in the frontal lobes corresponding to the area where ScO2 monitored.\n* Patients in pharmacological studies.\n* Patients with severe heart / lung / blood vessel diseases.'}, 'identificationModule': {'nctId': 'NCT01940861', 'briefTitle': 'Cerebral Oxymetry in Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Cerebral Oxymetry in Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'Co-TBI'}, 'secondaryIdInfos': [{'id': '2010/824', 'type': 'OTHER_GRANT', 'domain': 'OUS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Traumatic brain injury'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'state': 'Oslo County', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Ove Andreas Hagen, MD', 'role': 'CONTACT', 'email': 'ovahagen@online.no', 'phone': '+4790634748'}, {'name': 'Ove A. Hagen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}