Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT05552703
Status:
UNKNOWN
Last Update Posted:
2022-09-23
First Post:
2021-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Traumatic Extradural Hematoma in Paediatric Age Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046748', 'term': 'Hematoma, Epidural, Spinal'}], 'ancestors': [{'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-21', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glascow outcome scale', 'timeFrame': 'immediately after the intervention/procedure/surgery', 'description': 'The Glasgow Outcome Scale (GOS) categorizes the outcomes of patients after traumatic brain injury, as follows\n\n1. Persistent vegetative state: Minimal responsiveness\n2. Severe disability: Conscious but disabled; dependent on others for daily support\n3. Moderate disability: Disabled but independent; can work in sheltered setting\n4. Good recovery: Resumption of normal life despite minor deficits'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'immediately after the intervention/procedure/surgery, through study completion, an average of 1 year', 'description': 'patients who died after surgery'}, {'measure': 'morbidity', 'timeFrame': 'immediately after the intervention/procedure/surgery, through study completion, an average of 1 year', 'description': 'patients with disability after surgery'}]}, 'conditionsModule': {'keywords': ['paediatrics'], 'conditions': ['Extradural Hematoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://link.springer.com/article/10.1007/BF01808613', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the clinical and radiological characteristics of children with traumatic extradural hematoma and factors affecting the initial neurological status and outcome.', 'detailedDescription': 'Extradural hematoma (EDH) represents 2.7-4% of traumatic brain injury .EDH is a potentially lethal condition which is easily cured if diagnosed early .EDH is less frequent in pediatric age group than in adults. The mean age of pediatric patients harboring EDH is between 6 and 10 years and it is rare among infants under the age of 12 months. EDH in children differs significantly from adults in terms of mode of injury, prognostic factors, and outcome. EDH in children may follow a trivial trauma and the course is more insidious and associated skull fractures is less frequent and these factors make it difficult to diagnose and often challenging to manage. The reported rate of mortality from EDH in children is varying from 0% and 17%, The criteria for choosing the surgical evacuation Vs. conservative management in pediatric age group still ill-defined this is what encouraged the investigators to carry this study to present our experience in the management of EDH in children aged less than 18 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pediatric patients with traumatic extradural hematoma presenting at our institute and managed surgically.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pediatric patients with traumatic extradural hematoma presenting at our institute and managed surgically.\n\nExclusion Criteria:\n\n* Patients aged more than 18 years old.\n* patients with other traumatic brain injuries like: acute subdural hematoma, intra-cerebral hematoma and subarachnoid hemorrhage.'}, 'identificationModule': {'nctId': 'NCT05552703', 'briefTitle': 'Traumatic Extradural Hematoma in Paediatric Age Group', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Traumatic Extradural Hematoma in Paediatric Age Group', 'orgStudyIdInfo': {'id': 'EDH in paediatric'}}, 'armsInterventionsModule': {'interventions': [{'name': 'surgical evacuation of extradural hematoma', 'type': 'PROCEDURE', 'description': 'evacuation of extradural hematoma by craniotomy'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Ashraf', 'role': 'CONTACT', 'email': 'Mohamed.20134268@med.au.edu.eg', 'phone': '+201050815922'}, {'name': 'Mohamed Taghian, professor', 'role': 'CONTACT', 'email': 'Mtaghyan@gmail.com', 'phone': '+201006876892'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator,', 'investigatorFullName': 'Mohamed Ashraf Salah', 'investigatorAffiliation': 'Assiut University'}}}}