Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
Study NCT ID:
NCT04077268
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2019-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Becoming Traumatic Brain Injured Patients at Day 7 of Their Trauma
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-30', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-08-30', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Becoming of traumatic brain injured patients: becoming classified in alive with or without sequelae or death, by using scale of GOS E', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'To study the future of traumatic brain injured patients at day 7 of their trauma\n\nPrimary endpoint: Fate, classified as survival with or without sequelae, death. Use of the GOS-E scale to classify survival with or without sequelae. The collection of this scale will be done by telephone contact, 7 days of admission to the emergency room.\n\nSecondary judgment criteria:\n\n* Compendium of the realization of the CT / time respected between the TCL and the CT / Hospitalization / 2nd CT to realize at 24 hours in the patients treated by TAC or AAP\n* Application of the recommendations of the French Society of Emergency Medicine 2012: Become 7 days of patients classified according to whether or not the recommendations, .\n* Become TCL patients under AAP or TAC\n* Number of reconsultation, rehospitalization, new imaging within 7 days after TCL'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient add a head mild trauma and consult at the emergency of Poitiers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient of both sexes, at least 18 years old,\n* Patient with mild head trauma, Glasgow 13-15\n* Patient without tutorship or curatorship\n* Affiliation to social security\n* No opposition of the patient or relatives to participation in the study.\n\nExclusion Criteria:\n\n* Patient already included in this study\n* Refusal to participate in this search\n* Patient undergoing enhanced protection (persons deprived of liberty by a judicial or administrative decision, adults under legal protection).'}, 'identificationModule': {'nctId': 'NCT04077268', 'briefTitle': 'Becoming Traumatic Brain Injured Patients at Day 7 of Their Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Becoming Traumatic Brain Injured Patients at Day 7 of Their Trauma in Poitiers Emergency', 'orgStudyIdInfo': {'id': 'Distance'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GOS-E', 'type': 'OTHER', 'description': 'Call at 7 days, patients add a brain trauma to know their sequeals'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU of POITIERS', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}