Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT04707105
Status:
RECRUITING
Last Update Posted:
2021-03-18
First Post:
2021-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Cohort Study of Intracerebral Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 856}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2021-01-11', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients with a 3-month modified Rankin Scale (mRS) score≤ 3', 'timeFrame': '2-3years', 'description': 'mRS 0-6, higher indicate worse outcome'}], 'secondaryOutcomes': [{'measure': 'Absolute peripheral hematoma edema(PHE) growth', 'timeFrame': '2-3years', 'description': 'absolute peripheral hematoma edema growth in CT/MRI measured by picture archiving and communication systems(PACS) system'}, {'measure': 'Relative peripheral hematoma edema(rPHE)', 'timeFrame': '2-3years', 'description': 'rPHE：absolute PHE divided by hematoma volume in CT/MRI'}, {'measure': 'National institute of health stroke scale（NIHSS score）', 'timeFrame': '2-3years', 'description': 'NIHSS 0-42, higher indicate worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['primary intracerebral hemorrhage', 'hypertension', 'perihematomal edema', 'secondary brain injury', 'remote diffusion-weighted imaging lesions (R-DWILs)', 'immune response', 'multimodel image', 'cohort', 'MRI'], 'conditions': ['Intracerebral Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with intracerebral hemorrhage.', 'detailedDescription': 'Intracerebral hemorrhage (ICH) remains a devastating disease with high mortality, yet few therapeutic managements have been proved effective. Large quantities of work needs to be done to fully delineate the prevalence and prognosis of ICH. Hence, the investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective, treatments and prognosis of Chinese hospitalised adult patients with ICH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '856 hospitalized patients over 18 years old with primary intrcerebral hemorrhage will be enrolled consecutively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients over 18 years old of primary intracerebral hemorrhage.\n\nExclusion Criteria:\n\n1. patients of secondary intracerebral hemorrhage，such as hemorrhagic transformation of ischemic stroke, aneurysmal, cavernomas, arterio- venous malformations, central venous thrombosis, trauma-related, or tumor.\n2. isolated intraventricular hemorrhage or subarachnoid hemorrhage pregnant patients；\n3. surgical evacuation of hematoma；\n4. unavailability to get complete blood cell samples and presenting contraindications or refusal to MRI\n5. patients cannot be followed up for any reasons.\n6. patients death in 24 hours\n7. pregnant patients'}, 'identificationModule': {'nctId': 'NCT04707105', 'acronym': 'POSTER', 'briefTitle': 'Prospective Cohort Study of Intracerebral Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'A Prospective Observational Cohort Study in Chinese Patients With Primary Intracerebral Hemorrhage', 'orgStudyIdInfo': {'id': 'I2018001098'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'description': 'a prospective cohort of patients of primary intracerebral hemorrhage in Second Affiliated Hospital, School of Medicine, Zhejiang University'}, {'label': "Second People's Hospital of Hangzhou City, Zhejiang Province", 'description': "a prospective cohort of patients of primary intracerebral hemorrhage in Second People's Hospital of Hangzhou City, Zhejiang Province"}, {'label': '4th Affiliated Hospital, School of Medicine at Zhejiang University', 'description': 'a prospective cohort of patients of primary intracerebral hemorrhage in 4th Affiliated Hospital, School of Medicine at Zhejiang University'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Gao, MD,PhD', 'role': 'CONTACT', 'email': '2202012@zju.edu.cn', 'phone': '13588451471'}], 'facility': '2nd Affiliated Hospital, School of Medicine at Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Feng Gao, MD,PhD', 'role': 'CONTACT', 'email': '2202012@zju.edu.cn', 'phone': '13588451471'}, {'name': 'Lusha Tong, MD,PhD', 'role': 'CONTACT', 'phone': '15868171218'}], 'overallOfficials': [{'name': 'Feng Gao, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}