Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
Study NCT ID:
NCT04189068
Status:
COMPLETED
Last Update Posted:
2019-12-06
First Post:
2019-10-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fatal Cerebral Infarction After Nasal Augmentation With Hyaluronic Acid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-05', 'studyFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2019-12-05', 'lastUpdatePostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pulse', 'timeFrame': '0-6 day', 'description': 'Monitore the "beats per minute over the past 6 days.'}, {'measure': 'blood pressure', 'timeFrame': '0-6 day', 'description': 'Monitor the blood pressure and record with mm Hg over the past 6 days.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral Infarction Hyaluronic Acid Embolism'], 'conditions': ['Magnetic Resonance Angiography']}, 'referencesModule': {'references': [{'pmid': '26763725', 'type': 'BACKGROUND', 'citation': 'Li KT, Huang YH, Chen CH, Chou LW. Delayed-onset cerebral infarction after cosmetic facial injection using hyaluronic acid. J Formos Med Assoc. 2016 Jul;115(7):587-8. doi: 10.1016/j.jfma.2015.11.012. Epub 2016 Jan 4. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'this study discussed the pathogenesis, treatment, and prognosis of severe cerebral infarction and ophthalmic artery occlusion for Aisan induced by hyalruonic acid filler injection.', 'detailedDescription': 'Intra-arterial thrombolysis and retrobulbar injection of hyaluronidase have been used for HA-induced ophthalmic artery obstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with severe cerebral infarction and ophthalmic artery occlusion after nasal augmentation by HA.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of cerebral infarction\n\nExclusion Criteria:\n\n* fat embolism'}, 'identificationModule': {'nctId': 'NCT04189068', 'briefTitle': 'Fatal Cerebral Infarction After Nasal Augmentation With Hyaluronic Acid', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Fatal Cerebral Infarction and Ophthalmic Artery Occlusion After Nasal Augmentation With Hyaluronic Acid - A Case Report and Review', 'orgStudyIdInfo': {'id': 'ky20192199-c-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaan XI Province', 'country': 'China', 'facility': 'Qing', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Ma', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xijing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Clinical research', 'investigatorFullName': 'Yang Qing', 'investigatorAffiliation': 'Xijing Hospital'}}}}