Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT06629532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The REgistry Study on Multimodality trEAtment foR Cerebral Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100000}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2049-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-10-03', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2044-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Rankin Score (mRS)', 'timeFrame': 'at least 6 months', 'description': '0=no symptoms, 1=no significant disability, 2=slight disability, 3= moderate disability, 4=moderate severe disability, 5=severe disability, 6=death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intracerebral hemorrhage', 'Outcome', 'Management', 'Surgical interventions', 'Real-world', 'Disparities', 'Multicentric data'], 'conditions': ['Intracerebral Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The REgistry Study on multimodality trEAtment foR Cerebral Hemorrhage (RESEARCH) aims to address these challenges by establishing a comprehensive national registry. This initiative will collect detailed, longitudinal data on the clinical characteristics, treatment modalities, and outcomes of patients with ICH across various regions. By leveraging a wide array of treatment data - including medical management, surgical interventions, and rehabilitative strategies - the RESEARCH registry intends to provide a granular view of current treatment landscapes and their direct impact on patient recovery and quality of life.', 'detailedDescription': 'Cerebral hemorrhage, also known as intracerebral hemorrhage (ICH), is a severe neurological condition characterized by abrupt bleeding within the brain tissues, leading to high rates of mortality and morbidity worldwide. In China, where the burden of cerebrovascular diseases is substantial due to the aging population and prevalence of risk factors such as hypertension and diabetes, the impact of ICH is particularly pronounced. Despite advancements in medical science, the prognosis for patients suffering from ICH remains poor, with a high proportion of survivors experiencing significant disability.\n\nCurrent treatment protocols for ICH involve a range of strategies, from conservative management to surgical interventions. However, the heterogeneity in clinical practices and patient responses highlights a significant gap in standardized treatment efficacy.\n\nThis registry study is not only pivotal for enhancing the understanding of effective treatment combinations but also crucial for identifying potential disparities in the application of treatment modalities across different healthcare settings. Through the analytical power of this large-scale, multicentric data, RESEARCH will contribute significantly to optimizing treatment paradigms and ultimately, shaping policy changes that aim to reduce the mortality and enhance the recovery rates of patients suffering from cerebral hemorrhage.\n\nThere is an urgent need to evaluate these multimodal treatment approaches on a broader scale to understand their real-world effectiveness and develop guidelines that can be systematically applied to improve patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cerebral hemorrhage from various causes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cerebral hemorrhage\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06629532', 'acronym': 'RESEARCH', 'briefTitle': 'The REgistry Study on Multimodality trEAtment foR Cerebral Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'The George Institute'}, 'officialTitle': 'The REgistry Study on Multimodality trEAtment foR Cerebral Hemorrhage', 'orgStudyIdInfo': {'id': 'Thegeorgeinstitute'}, 'secondaryIdInfos': [{'id': '82071390', 'type': 'OTHER_GRANT', 'domain': 'National Natural Science Foundation of China'}, {'id': '82271394', 'type': 'OTHER_GRANT', 'domain': 'National Natural Science Foundation of China'}, {'id': '8247050928', 'type': 'OTHER_GRANT', 'domain': 'National Natural Science Foundation of China'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'medical management, surgical interventions, and rehabilitative strategies', 'type': 'OTHER', 'description': 'By leveraging a wide array of treatment data - including medical management, surgical interventions, and rehabilitative strategies - the RESEARCH registry intends to provide a granular view of current treatment landscapes and their direct impact on patient recovery and quality of life.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tao Liu, MD', 'role': 'CONTACT', 'email': 'TLiu1@georgeinstitute.org.au', 'phone': '61-466068193', 'phoneExt': '86-18302204804'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tao Liu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Tao Liu', 'investigatorAffiliation': 'The George Institute'}}}}