Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-25 @ 3:33 AM
Study NCT ID:
NCT04877405
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2021-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study of Intracerebral Hemorrhage Patients in Hospital Parc Taulí
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hematoma growth', 'timeFrame': '2 days', 'description': 'Difference of hematoma size between CT conducted at admission and MRI conducted during follow up'}, {'measure': 'Correlation between hematoma growth and clinical paramenters', 'timeFrame': '2 days', 'description': 'Determine the clinical parameters related with hematoma growth'}, {'measure': 'Correlation between hematoma growth and analytical parameters', 'timeFrame': '2 days', 'description': 'Determine the analytical parameters related with hematoma growth'}, {'measure': 'Perilesional edema', 'timeFrame': '2 days', 'description': 'Size of edema measured in FLAIR sequences'}, {'measure': 'Correlation between clinical parameters and the size of edema measured in FLAIR sequences', 'timeFrame': '2 days', 'description': 'Determine the relationship between clinical parameters and the size of edema'}, {'measure': 'Correlation between analytical parameters and the size of edema measured in FLAIR sequences', 'timeFrame': '2 days', 'description': 'Determine the relationship between analytical parameters and the size of edema'}, {'measure': 'Alterations in DWI', 'timeFrame': '2 days', 'description': 'Size of alterations in diffusion weighted image'}, {'measure': 'Correlation between clinical parameters and the size of alterations in DWI', 'timeFrame': '2 days', 'description': 'Determine the relationship between clinical parameters and the size of alterations in DWI'}, {'measure': 'Correlation between analytical parameters and the size of alterations in DWI', 'timeFrame': '2 days', 'description': 'Determine the relationship between analytical parameters and the size of alterations in DWI'}, {'measure': 'Correlation between hematoma growth and clinical outcome', 'timeFrame': '1 month', 'description': 'Determine the impact of hematoma growth on clinical outcome'}, {'measure': 'Correlation between perilesional edema size and clinical outcome', 'timeFrame': '1 month', 'description': 'Determine the relationship between the size of edema and clinical outcome'}, {'measure': 'Correlation between the size of DWI alterations and clinical outcome', 'timeFrame': '1 month', 'description': 'Determine the relationship between the size of DWI alterations and clinical outcome'}, {'measure': 'Correlation between the clinical parameters and clinical outcome', 'timeFrame': '1 month', 'description': 'Determine the relationship between the clinical parametes and clinical outcome'}, {'measure': 'Correlation between the analyticial parameters and clinical outcome', 'timeFrame': '1 month', 'description': 'Determine the relationship between the analytical parametes and clinical outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracerebral Hemorrhage']}, 'descriptionModule': {'briefSummary': 'This is a retrospective observational study to investigate the clinical, analytical and neuroimaging data generated during routine clinical management of intracerebral hemorrhage. The study will review the data from about 500 patients attended during the last ten years in the Neurology Department of Hospital Parc Taulí de Sabadell.\n\nThe aim is to measure the size of the lesion in neuroimage (TC and MRI), the edema, the alterations in diffusion weighted images and to correlate this data with clinical parameters and analytical measurements. With this approach investigators plan to investigate the incidence of hematoma growth, the role of perilesional edema and diffusion changes, and the relation between neuroimaging findings and clinical outcome. The study also try to establish significant correlations between clinical and analytical data, the clinical outcome and and the magnitude of changes in neuroimaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consist in the patients attended due to spontaneous intracerebral hemorrhage in Hospital Parc Taulí de Sabadell during the last decade. Traumatic or oncologic origin of the hemorrhage constitute exclusion criteria of the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been attended at the Hospital Parc Taulí for the last 10 years after presenting an intraparenchymal hemorrhage.\n* The patients have had to undergo a computed tomography at the admission and a cranial magnetic resonance during the hospitalization in the time course specified in point in the protocol\n* The patients must present in their clinical story the analytical determinations detailed in the protocol.\n\nExclusion Criteria:\n\n* Intracerebral hemorrhage secondary to head trauma\n* Intracerebral hemorrhage secondary to neoplasm'}, 'identificationModule': {'nctId': 'NCT04877405', 'briefTitle': 'Retrospective Study of Intracerebral Hemorrhage Patients in Hospital Parc Taulí', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Autonoma de Barcelona'}, 'officialTitle': 'Retrospective Study to Identify Correlations Between the Clinical Parameters, Analytics and Neuroimaging Data in Patients That Suffered of Intraparenchymal Cerebral Hemorrhage', 'orgStudyIdInfo': {'id': 'UHA-2021-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intracerebral hemorraghe', 'description': 'Patients that suffered an intracerebral hemorraghe and that have been subjected to CT and MRI scans', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This observational study is not focused on therapeutic intervention', 'armGroupLabels': ['Intracerebral hemorraghe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08193', 'city': 'Cerdanyola del Vallès', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Santiago Rojas Codina MD PhD', 'geoPoint': {'lat': 41.49109, 'lon': 2.14079}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD may be shared with other researchers under request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Autonoma de Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Parc Taulí Hospital Universitari', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Santiago Rojas Codina MD PhD', 'investigatorAffiliation': 'Universitat Autonoma de Barcelona'}}}}