Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-06 @ 2:03 PM
Study NCT ID:
NCT03293420
Status:
COMPLETED
Last Update Posted:
2017-09-26
First Post:
2017-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-25', 'studyFirstSubmitDate': '2017-09-21', 'studyFirstSubmitQcDate': '2017-09-25', 'lastUpdatePostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor score', 'timeFrame': 'At baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Head Injury']}, 'descriptionModule': {'briefSummary': 'Observational retrospective study that included all patients meeting the inclusion criteria from 1st January 2014 to 31st December 2015.\n\nThe objective of the study is to describe and compare two populations of patients with severe traumatic head injury arriving under sedation in the Department in whom the sedation was not continued.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with traumatic head injury', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with traumatic head injuring arriving in the Neurosurgery and Traumatologic Intensive Care Unit under sedation\n\nExclusion Criteria:\n\n* Brain death within the 48h following admission,\n* Stroke leading to the traumatic head injury,\n* Death within the 24h following admission,\n* Patients not under sedation on admission to the unit,\n* Non-sedated patients transferred directly to the operating theatre\n* Traumatic brain injury in patients presenting chronic sub-dural haematoma,\n* Continued sedation (\\> 15h) in the ICU.'}, 'identificationModule': {'nctId': 'NCT03293420', 'acronym': 'PRECOCE TC', 'briefTitle': 'Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early', 'orgStudyIdInfo': {'id': 'LITTEL-GIRARD 2016'}}, 'contactsLocationsModule': {'locations': [{'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}