Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT02418169
Status:
UNKNOWN
Last Update Posted:
2015-04-16
First Post:
2015-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Craniofacial Fractures and Brain Injuries: Diagnostic and Therapeutic Considerations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D012887', 'term': 'Skull Fractures'}], 'ancestors': [{'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'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-15', 'studyFirstSubmitDate': '2015-04-13', 'studyFirstSubmitQcDate': '2015-04-15', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Brain Injuries', 'Skull Fractures']}, 'descriptionModule': {'briefSummary': 'This study evaluates the association between traumatic brain injuries and craniofacial or/and skull fractures. Purpose is to find out the amount of missed diagnoses and improve primary diagnostics of trauma patients.', 'detailedDescription': "A part of mild TBIs remains undiagnosed. Therefore the primary diagnostics of trauma patients needs to be improved. According to some studies, a part of trauma patients' concomitant injuries weren't diagnosed in the emergency room (ER) but were diagnosed later in the clinics. In addition to difficult diagnostics the treatment of these patients demands close co- operation between many specialities.\n\nThe aim of this study is to evaluate the association between TBIs and facial fractures. The real amount of facial fractures in patients with severe TBI and the clinical significance of these fractures are evaluated. Also the number of patients with facial fractures and a concomitant TBI is evaluated. The aim is to find out the amount of patients with missed diagnoses. Other aims of are to determine the effect of the type or location of a facial fracture on the in- cidence and severity of TBI. With the help of the results it would be possible to improve the comprehensive diagnostics and early treatment of patients with a facial fracture or a TBI.\n\nThe retrospective and prospective data on patients with TBI and/or facial fracture are collect- ed at Turku University Hospital. The comparison of the two groups will give information on the amount of patients with missed diagnosis of TBI or facial fracture. The results can be utilised in planning strategy for comprehensive diagnostics and treatment of the patients. In the research group the investigators have specialists in the fields of oral and maxillofacial surgery, neurol- ogy and otorhinolaryngology."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe traumatic brain injury, patients with craniofacial fractures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe traumatic brain injury, GCS 8 or less and/or Craniofacial fracture\n\nExclusion Criteria:\n\n* Died before admitted to hospital'}, 'identificationModule': {'nctId': 'NCT02418169', 'briefTitle': 'Association Between Craniofacial Fractures and Brain Injuries: Diagnostic and Therapeutic Considerations', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Association Between Craniofacial Fractures and Brain Injuries: Diagnostic and Therapeutic Considerations', 'orgStudyIdInfo': {'id': 'T74/2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'retrospective, severe traumatic brain injury', 'description': 'All patients in 2010-2014 with severe traumatic brain injury admitted to Turku University Central Hospital (TUCH)'}, {'label': 'retrospective, craniofacial fracture', 'description': 'All patients in 2010-2014 with craniofacial fracture admitted to TUCH.'}, {'label': 'prospective, severe traumatic brain injury', 'description': 'All patients in 2015-2017 with severe traumatic brain injury admitted to Turku University Central Hospital (TUCH)'}, {'label': 'prospective, craniofacial fracture', 'description': 'All patients in 2015-2017 with craniofacial fracture admitted to TUCH.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}