Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-30 @ 6:19 AM
Study NCT ID:
NCT04621357
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2020-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Cerebral Oedema in Intracerebral Haemorrhage
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2020-10-29', 'studyFirstSubmitQcDate': '2020-11-05', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Poor functional outcome defined as a modified Rankin Scale of 4 or more', 'timeFrame': 'at 3 months'}], 'secondaryOutcomes': [{'measure': 'overall distribution of the modified Rankin scale at 3- and 12 months', 'timeFrame': 'at 3 months and 12 months', 'description': 'The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.\n\nThe scale runs from 0-6, running from perfect health without symptoms to death.'}, {'measure': 'Early neurological deterioration defined as more than 4 points on the NIHSS score', 'timeFrame': 'at 96 hours', 'description': 'The NIHSS score (NIH Stroke Scale) is used to monitor the progression of an ischemic or hemorrhagic stroke. It is rated from 0 to 42 points. Depending on the result, a distinction is made from Minor stroke to Severe stroke'}, {'measure': 'all-cause mortality at 3 and 12 months', 'timeFrame': 'at 3 and 12 months'}, {'measure': 'Cognitive decline', 'timeFrame': 'at 3 months, at 12 months', 'description': 'Cognitive decline defined as a score on MOCA test below 27'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intra Cerebral Hemorrhage', 'Perihaematomal oedema', 'MRI', 'outcome'], 'conditions': ['Stroke', 'Intra Cerebral Hemorrhage']}, 'descriptionModule': {'briefSummary': 'In 2020, IntraCerebral Haemorraghe (ICH) remains the most devastating type of stroke. Besides stroke unit care, no specific treatment has been proven effective yet. Perihaematomal oedema (PHO) could be a promising therapeutic target. However, the mechanisms, the natural history as well as the clinical impact of this PHO remain unclear. The COPITCH study has been designed to answer these questions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With a spontaneous ICH, i.e. non traumatic\n* Admitted within 12 hours of stroke onset. For wake-up strokes, time of last seen well will be considered as stroke onset\n* Patient insured under the French social security\n* Consent form signed\n\nExclusion Criteria:\n\n* Pure intraventricular haemorrhages\n* "secondary" ICH: ICH resulting from intracranial vascular malformation, intracranial venous thrombosis, head trauma or tumour; haemorrhagic transformation within an infarct\n* Pre-admission modified Rankin score of 4 or 5\n* Life expectancy of less than 1 year related to comorbidities (end stage cancer, end stage organ failure)\n* Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done)\n* Adults who are deprived of their liberty by judicial or administrative decision\n* Referral from other hospitals\n* Contra-indication to MRI : claustrophobia, ocular metallic foreign bodies (accidental or other) or in a risk area (nervous or vascular system);irremovable implanted medical device (pacemaker, neurostimulator, cochlear implants and others);metallic heart valve (mainly old heart valves) or vascular clips previously implanted on cranial aneurysms; gadolinium allergy\n* No consent form'}, 'identificationModule': {'nctId': 'NCT04621357', 'acronym': 'COPITCH', 'briefTitle': 'Influence of Cerebral Oedema in Intracerebral Haemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage', 'orgStudyIdInfo': {'id': '2017_70'}, 'secondaryIdInfos': [{'id': '2019-A02502-55', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient with intracerebral haemorrhage', 'description': 'Patients will be screened at admission in the stroke units right after brain MRI demonstrating the presence of blood in the brain parenchyma.', 'interventionNames': ['Radiation: Brain MRI', 'Biological: Biological biomarkers']}], 'interventions': [{'name': 'Brain MRI', 'type': 'RADIATION', 'description': 'Brain MRI will include differents sequences.', 'armGroupLabels': ['Patient with intracerebral haemorrhage']}, {'name': 'Biological biomarkers', 'type': 'BIOLOGICAL', 'description': 'Biological biomarkers will include a set of systemic inflammatory markers', 'armGroupLabels': ['Patient with intracerebral haemorrhage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'CORDONNIER Charlotte, MHD, PHD', 'role': 'CONTACT', 'email': 'charlotte.cordonnier@chu-lille.fr', 'phone': '0320446814', 'phoneExt': '+33'}], 'facility': 'CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Charlotte Cordonnier, MD,PhD', 'role': 'CONTACT', 'email': 'charlotte.cordonnier@chu-lille.fr', 'phone': '0320445962', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Charlotte Cordonnier, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conseil Régional Hauts-de-France, France', 'class': 'UNKNOWN'}, {'name': 'Fondation pour la recherche sur les AVC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}