Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 6:22 PM
Study NCT ID:
NCT05158660
Status:
UNKNOWN
Last Update Posted:
2021-12-15
First Post:
2021-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Intracerebral Hematoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], 'ancestors': [{'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-03', 'studyFirstSubmitDate': '2021-12-03', 'studyFirstSubmitQcDate': '2021-12-03', 'lastUpdatePostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in volume of intracerebral hematoma', 'timeFrame': 'at baseline, then 24 hour after the baseline, and finally 48 hours after the baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracerebral Hematoma']}, 'descriptionModule': {'briefSummary': 'The study will assess acute intracerebral hematoma expansion within the first 48 hours from the onset using transcranial duplex sonography in patients who have acute intracerebral hematoma , and will also assess the correlation between the transcranial duplex sonography measurements and the clinical outcome of these patients .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. first ever non traumatic supratentorial primary intracerebral haemorrhage on non contrast CT brain\n2. admitted within 24 hours of symptom onset\n\nExclusion Criteria:\n\n1. blood diseases, decompansated hepatic or renal impairment, or encephalopathy caused by electrolyte disturbance\n2. on anticoagulant treatment\n3. if devolped major complications during hospitalization ( e.g sever chest infection, hypoxia, or deep venous thrombosis )\n4. comorbid neurological or psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT05158660', 'briefTitle': 'Assessment of Intracerebral Hematoma', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Intracerebral Hematoma Using Transcranial Duplex _ Hospital Based Study', 'orgStudyIdInfo': {'id': 'intracerebral hematoma'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients assessed by transcranial duplex sonography', 'interventionNames': ['Device: transcranial duplex sonography']}], 'interventions': [{'name': 'transcranial duplex sonography', 'type': 'DEVICE', 'description': 'it is an imaging device that will measure the intracerebral hematoma expansion', 'armGroupLabels': ['patients assessed by transcranial duplex sonography']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'waleed Gafar', 'role': 'CONTACT', 'email': 'waleed.gafar1995@gmail.com', 'phone': '00201012110708'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Waleed Mohammed Gafar', 'investigatorAffiliation': 'Assiut University'}}}}