Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-31 @ 11:40 PM
Study NCT ID:
NCT05035134
Status:
UNKNOWN
Last Update Posted:
2021-09-05
First Post:
2021-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Circulating Exosomes in Early Diagnosis and Prognosis Evaluation After Intracerebral Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The type and content of circulating exosomes', 'timeFrame': 'within 24 hours of ICH', 'description': 'After the exosomes were isolated, RNA sequencing and proteome sequencing were performed to identify the change of circulating exosomes'}, {'measure': 'Modified Rankin scale (mRS) scores', 'timeFrame': 'from onset to three months or six months', 'description': 'mRS scores was divided into seven grades (0-6). The higher the score, the more severe the symptoms'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'through study completion，an average of 1 year'}, {'measure': 'hospital stay', 'timeFrame': 'From hospitalization to discharge，up to one month'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracerebral Hemorrhage；Circulating Exosomes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe the relationship between the changes of circulating exosomes and the development and outcome of the disease in patients with intracerebral hemorrhage, and to search for early serum markers and potential intervention targets for disease monitoring in patients with intracerebral hemorrhage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All of the ICH patients receiving treatment in Tangdu Hospital during 2021-2022', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. No systematic treatment was given before admission;\n2. The patients were diagnosed with cerebral hemorrhage, and had imaging evidence;\n3. The age was more than 18 years old;\n4. The patient or family member agrees to sign the informed consent.\n\nExclusion Criteria:\n\n1. Hematoma is caused by secondary factors (intracranial tumor, arteriovenous malformation or aneurysm);\n2. Bleeding into the ventricle;\n3. Multiple cerebral hemorrhage;\n4. The patient did not receive treatment in our hospital;\n5. Severe disability, dementia, or organ dysfunction before onset\n6. Coagulopathy or long-term use of anticoagulants\n7. Hematoma affects brain stem\n8. Subjects refused to participate'}, 'identificationModule': {'nctId': 'NCT05035134', 'briefTitle': 'Application of Circulating Exosomes in Early Diagnosis and Prognosis Evaluation After Intracerebral Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'Application of Circulating Exosomes in Early Diagnosis and Prognosis Evaluation After Intracerebral Hemorrhage', 'orgStudyIdInfo': {'id': 'TDSJWKICHEX'}}, 'contactsLocationsModule': {'locations': [{'city': "Xi'an", 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xun Wu, M.D', 'role': 'CONTACT', 'email': '2645302700@qq.com', 'phone': '86-15609261331'}], 'facility': 'Tandu Hospital, Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Xun Wu, M.D', 'role': 'CONTACT', 'email': '2645302700@qq.com', 'phone': '86-15609261331'}], 'overallOfficials': [{'name': 'Yan Qu, M.D, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Tang-Du Hospital'}, {'name': 'Xun Wu, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tang-Du Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}