Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-28 @ 11:47 PM
Study NCT ID:
NCT06119932
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of One Burr Hole Evacuation for Subdural Hematoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}], 'ancestors': [{'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-05', 'studyFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2023-11-05', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ClinicalEvaluation of evacuation for subdural hematoma by one burrhole', 'timeFrame': '72 hours post operative', 'description': '* glasgo coma scale,\n* neurological deficit,\n* clinical symptoms (seizures) .'}], 'secondaryOutcomes': [{'measure': 'Radiological evaluation for outcome', 'timeFrame': '72 hours post operative', 'description': 'Nearly gross total evacuation according to confirmation by postoperative CT brain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subdural Hematoma']}, 'descriptionModule': {'briefSummary': 'To evaluate the outcome of one burrhole evacuation for subdural hematoma and it has the same result of traditional two burrhole', 'detailedDescription': '* Subdural hematoma (SDH): abnormal Collection of Liquefied blood degradation underneath the dura matter (1.2.3).\n* one of the most frequent types of intracranial haemorrhage, That is still associated with significant morbidity (1.4.5).\n* The SDH: is a common disease in elderly Patient, and Its Incidence is highest in persons older than 70 Years of age (1.5).\n* Types of Subdural hematoma(18.19)\n\n 1- Acute: present within 48-72 hours of injury. 2. Sub-acute: manifest itself between 3-20 day. 3- Chronic (CH): produce symptoms from 3 weeks to several months after injury Risk Factors: (7.8.9.10.11.12)\n 1. Trauma; mostly minor Trauma, Approximately two thirds of The Patients have suffered one. Reports exist of chronic SDH due to birth trauma in neonates.\n 2. Advanced age: The elderly are at risk due to:\n\n 1. brain atrophy, whereby The bridging veins are stretched and become more fragile.\n 2. Older People tend to fall more often and Suffer minor head trauma.\n 3. With increase age, The incidence of blood Thinner administration raises leading to increased risk for haemorrhage\n 3. Chronic alcoholism:\n 4. Gender: men, from all age groups, suffer higher rates of chsDH than woman.\n 5. CoagulaPathy: Therapeutic anticoagulation and antiplatelet therapy.\n 6. Medical Conditions: sepsis, hepatic failure, hemophilia, DIC and renal dialysis.\n 7. Intracranial hypotension: as after ventriculoperitoneal shunt. clinical presentation (1.13)\n* Symptoms of increase intra cranial pressure: Headache, Nausea, vomiting.\n* Focal neurological deficit - (weakness, aphasia).\n* Disturbed conscious level (DCL)\n* Seizures\n* Imaging investigation:\n\nCT brain (14.15)\n\n* Management : (1.6.16.17)\n\n 1. Conservative: A watch, wait and re-scan Policy is usually recommended in asymptomatic or minimally symptomatic patient with a thin CHSDH.\n 2. Surgical: For symptomatic (SDH) a- burr hole drainage B-twist drill drainage c- craniotomy\n* prognostic factors : (2.5) 1- age of patient 2- Associated chronic diseases like hypertension, liver diseases …….Etc 3- Laboratory investigation like Hb , platlate count ,pc,and PT. 5- Hematoma thickness 6- number of burr hole : one or two burr hole'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Both sex Adult obove 18 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with subdural hematoma either unilateral or bilateral\n* fit for surgery\n* Chronic SDH\n* Subacute SDH\n* Age: patients older than 18 years old\n* SEX: Both sex\n\nExclusion Criteria:\n\n* Patients unfit for surgery\n* Acute SDH\n* subdural hyroma\n* subdural empyema\n* patient treated conservatively'}, 'identificationModule': {'nctId': 'NCT06119932', 'briefTitle': 'Evaluation of One Burr Hole Evacuation for Subdural Hematoma', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of One Burr Hole Evacuation for Subdural Hematoma', 'orgStudyIdInfo': {'id': 'Subdural hematoma'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Evacuation for subdural hematoma by one burrhole', 'type': 'PROCEDURE', 'description': 'Evacuation for subdural hematoma by one burrhole'}]}, 'contactsLocationsModule': {'locations': [{'zip': '61631', 'city': 'Minya', 'state': 'Malawi', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed Lotfi a, Reseddnt', 'role': 'CONTACT'}], 'facility': 'Mohammed lotfi abdelkareem', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}, {'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed Lotfi', 'role': 'CONTACT'}], 'facility': 'Mohammed lotfi abdelkareem', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mohammed Lotfi, Resident', 'role': 'CONTACT', 'email': 'Mohammedlotfi029@gmail.com', 'phone': '01147341661'}, {'name': 'Ahmed Abo kresha, Professor', 'role': 'CONTACT', 'phone': '+201006814906'}], 'overallOfficials': [{'name': 'Shady Hassaan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of Neurosurgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurosurgical resident', 'investigatorFullName': 'Mohammed lotfi abdelkareem', 'investigatorAffiliation': 'Assiut University'}}}}