Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:35 PM
Study NCT ID:
NCT04798157
Status:
UNKNOWN
Last Update Posted:
2021-03-15
First Post:
2021-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcranial Doppler in Children With Hemoglobinopathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2023-01-27', 'unreleaseDate': '2023-02-05'}, {'resetDate': '2023-11-16', 'releaseDate': '2023-02-05'}], 'estimatedResultsFirstSubmitDate': '2023-01-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006453', 'term': 'Hemoglobinopathies'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017585', 'term': 'Ultrasonography, Doppler, Transcranial'}], 'ancestors': [{'id': 'D004453', 'term': 'Echoencephalography'}, {'id': 'D009485', 'term': 'Neuroradiography'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-03-12', 'lastUpdatePostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the blood flow velocities at the circle of Willis', 'timeFrame': 'At procedure exam time', 'description': 'The children will be be subjected to Transcranial Doppler (TCD ) , and velocity indices will be obtained , the subjects will be classified according the TAMMV (time average mean maximum velocities ) into high risk group with TAMMV \\> 200 cm/sec , and normal group \\<170 cm/sec , and conditional group with TAMMV 170-200 cm/sec .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemoglobinopathies']}, 'descriptionModule': {'briefSummary': 'Transcranial Doppler ultrasonography (TCD) is a noninvasive, portable technique for evaluating the intracranial vasculature.\n\nTCD ultrasonography is performed placing a low frequency (≤ 2 MHz) transducer on the scalp of the patient, in order to visualize the intracranial arterial vessels through specific acoustic windows, where bone is thinner, and evaluate cerebral blood flow velocity (CBFV) .\n\nPatients diagnosed to have hemoglobinopathy conditions with its most common forms thalassemia and sickle cell disease manifest both biochemical and clinical evidence of hypercoagulability conditions include deep venous thrombosis, pulmonary emboli and recurrent arterial occlusion .\n\nCerebrovascular accidents can be identified using transcranial Doppler ultrasonography which enables evaluation of cerebral artery blood flow velocity with a sensitivity of 90% and specificity of 100 % when compared with cerebral angiography .\n\nAccording to the stroke prevention trial in sickle cell anemia (STOP) study ,TCDs were classified based on blood velocity in the circle of Willis, expressed as time averaged mean of the maximum velocity (TAMMV). Children with abnormal, high velocities (\\>200cm/s) were at increased risk of stroke, which was reduced by 90% after starting regular blood transfusions. TAMMVs less than 170cm/s were classified as normal with annual TCD scanning recommended, whereas velocities between 170 and 200cm/s were called conditional, and followed up more closely without starting transfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children diagnosed with hemoglobinopathies\n\nExclusion Criteria:\n\n* Children before two years old .\n* Hemoglobinopathy patients more than 18 years .\n* Uncooperative patients .'}, 'identificationModule': {'nctId': 'NCT04798157', 'briefTitle': 'Transcranial Doppler in Children With Hemoglobinopathies', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Role of Transcranial Doppler (TCD) in Children With Hemoglobinopathies', 'orgStudyIdInfo': {'id': 'Soh-Med-21-03-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Children with Hemoglobinopathies', 'description': 'children from 2-18 years old , diagnosed to have hemoglobinopathy disease', 'interventionNames': ['Radiation: transcranial doppler']}], 'interventions': [{'name': 'transcranial doppler', 'type': 'RADIATION', 'description': 'Transcranial Doppler ultrasonography will be done using the ultrasound machine by placing a transducer over the relatively thinner temporal and occipital bones in order to visualize and evaluate the velocities at the circle of Willis.', 'armGroupLabels': ['Children with Hemoglobinopathies']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed E. Mohamed, ass. teacher', 'role': 'CONTACT', 'email': 'mohammad.albadry2012@gmail.com', 'phone': '+201030826466'}], 'overallOfficials': [{'name': 'Mohamed E. Mohamed, ass. teacher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of medicine Sohag university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'teaching assistant , faculty of medicine , Sohag university', 'investigatorFullName': 'Mohamed Ahmed Elbadry Mohamed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-01-27', 'type': 'RELEASE'}, {'date': '2023-02-05', 'type': 'UNRELEASE'}, {'date': '2023-02-05', 'type': 'RELEASE'}, {'date': '2023-11-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mohamed Ahmed Elbadry Mohamed, teaching assistant , faculty of medicine , Sohag university, Sohag University'}}}}