Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT06670456
Status:
RECRUITING
Last Update Posted:
2024-11-01
First Post:
2024-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Cohort of Patients With Intracerebral Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], 'ancestors': [{'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': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1\\. Peripheral blood; 2. Cerebrospinal fluid; 3. Evacuated hematoma, cerebral tissue, and/or bone flap. (No for everyone)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurological Function', 'timeFrame': 'Discharge; 3, 6, 12 months after enrollment', 'description': 'Assessed with modified Rankin Scale (0-6)'}, {'measure': 'Mortality', 'timeFrame': 'Discharge; 3, 6, 12 months after enrollment'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'Admission period; the 3, 6, 12 months after enrollment', 'description': 'Lately stoke, epilepsy, infections, cardiac event, ebolism.'}, {'measure': 'Cognitive Status', 'timeFrame': 'The 3, 6, 12 months after enrollment', 'description': 'Assessed with Telephone Interview for Cognitive Status - Modifed scale (0-51) Chinese version'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intracerebral Hemorrhage'], 'conditions': ['Stroke, Acute', 'Intracerebral Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The investigators designed a multicentral, observational, prospective cohort study to provide cortical data for risk stratification and biomarkers on early outcomes, complications, long-term neurological function, and cognitive status of spontaneous intracerebral hemorrhage patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were diagnosed with spontaneous intracerebral hemorrhage and received no surgical intervention until enrollment; and those patients should have enough life expectancy and be assessable for the interview, according to their pre-stroke status.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with spontaneous intracerebral hemorrhage (ICH) through skull radiologic scans (CT or MRI);\n* Underwent no surgical intervention;\n\nExclusion Criteria:\n\n* Secondary intracerebral hemorrhage (with leading cause, e.g., Moyamoya disease, arteriovenous malformation, intracranial aneurysm, tumor, brain trauma)\n* Pre-stroke life expectancy \\< 1 year for severe comorbidities (e.g., Progressive malignant tumor, severe chronic heart failure \\[NYHA: III-IV\\], severe chronic obstructive pulmonary disease \\[III-IV\\], chronic kidney disease requiring hemodialysis)\n* Severe dependency or incorporation to interview (e.g., pre-stroke mRS\\>3, severe dementia, intractable mental disease)\n* Unsuitable for inclusion in the study in the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT06670456', 'briefTitle': 'Prospective Cohort of Patients With Intracerebral Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Fujian Medical University'}, 'officialTitle': 'Multicentral Observational Prospective Cohort of Patients With Spontaneous Intracerebral Hemorrhage', 'orgStudyIdInfo': {'id': '2022ZD01003'}}, 'contactsLocationsModule': {'locations': [{'zip': '350004', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fu-xin Lin, MD', 'role': 'CONTACT', 'email': 'lfxstudy@126.com', 'phone': '86 13552358381'}, {'name': 'Yan Zheng', 'role': 'CONTACT', 'email': 'zhengyan1997med@foxmail.com', 'phone': '86 15659781312'}], 'facility': 'First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Quanzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian-cai Chen', 'role': 'CONTACT', 'phone': '86 13859736832'}, {'name': 'Nao-nan Weng', 'role': 'CONTACT', 'phone': '86 13506910771'}], 'facility': 'Anxi County Hospital', 'geoPoint': {'lat': 24.91389, 'lon': 118.58583}}, {'city': 'Quanzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xie-li Guo', 'role': 'CONTACT', 'phone': '86 15960795588'}, {'name': 'Zhen Qi', 'role': 'CONTACT', 'phone': '86 15880886519'}], 'facility': 'Jinjiang Municipal Hospital', 'geoPoint': {'lat': 24.91389, 'lon': 118.58583}}, {'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian-wu Long', 'role': 'CONTACT', 'phone': '86 13859934007'}, {'name': 'Chun Luo', 'role': 'CONTACT', 'phone': '86 15960802895'}], 'facility': 'The Second Affiliated lospital of Xiamen Medical College', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Zhangzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei-wei Wang', 'role': 'CONTACT', 'phone': '86 13806904186'}, {'name': 'Zhang Guo', 'role': 'CONTACT', 'phone': '86 13605011127'}], 'facility': 'Zhangzhou Municipal Hospital', 'geoPoint': {'lat': 24.51333, 'lon': 117.65556}}, {'city': 'Liaocheng', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei-dong Liu', 'role': 'CONTACT', 'phone': '86 15806976699'}, {'name': 'Han-yu Sun', 'role': 'CONTACT', 'phone': '86 15910197887'}], 'facility': "Liaocheng People's Hospital", 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}], 'centralContacts': [{'name': 'De-zhi Kang, MD', 'role': 'CONTACT', 'email': 'kdz99988@vip.sina.com', 'phone': '86 15759413951'}, {'name': 'Fu-xin Fu-xin, MD', 'role': 'CONTACT', 'email': 'lfxstudy@126.com', 'phone': '86 13600893154'}], 'overallOfficials': [{'name': 'De-zhi Kang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Fujian Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Deidentified case data are available from the authors upon reasonable request, after request in writing to the corresponding authors and after approval by the study committee and principal investigators from each site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'De-zhi Kang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fuzhou University', 'class': 'OTHER'}, {'name': 'Fujian Medical University', 'class': 'OTHER'}, {'name': 'National Institute of Hospital Administration (China)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'De-zhi Kang', 'investigatorAffiliation': 'First Affiliated Hospital of Fujian Medical University'}}}}