Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT05276934
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2022-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017542', 'term': 'Aneurysm, Ruptured'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}], 'ancestors': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2022-02-15', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in brain hypoperfusion', 'timeFrame': 'Change between day 0, 5, 9 after Intracranial Hemorrhage', 'description': 'Brain hypoperfusion in arterial territories assessed by the delays on perfusion Time to drain (seconds) on CT and/or MR perfusion'}], 'secondaryOutcomes': [{'measure': 'Change in vessel size', 'timeFrame': 'Change between day 0, 5, 9 after Intracranial Hemorrhage', 'description': 'Change in the vessel size measured on digital subtraction angiography (DSA) and computed tomography angiogram (CTA) in millimeters'}, {'measure': 'Time to next endovascular intervention for vasospastic stenosis', 'timeFrame': 'Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks', 'description': 'Delay between two procedures for the same indication'}, {'measure': 'Transcranial Doppler', 'timeFrame': 'Change between day 0, 5, 9 after Intracranial Hemorrhage', 'description': 'Reduction in intracranial vasospasm assessed by the targeted vessel velocity in meters per second'}, {'measure': 'Brain Hypoperfusion 2', 'timeFrame': 'Change between day 0, 5, 9 after Intracranial Hemorrhage', 'description': 'Reduction in brain hypoperfusion assessed by the volumes on different perfusion parameters time to peak (in seconds) on CT and/or MR perfusion'}, {'measure': 'Change in Glasgow coma scale', 'timeFrame': 'Change between day 0, 5, 9 after Intracranial Hemorrhage', 'description': 'Glasgow coma scale (GCS between 3 and 15, a higher score means a better outcome)'}, {'measure': 'Change in National Institutes of Health Stroke Scale score', 'timeFrame': 'Change between day 0, 5, 9 after Intracranial Hemorrhage', 'description': 'National Institutes of Health Stroke Scale (NIHSS between 0 and 42, a higher score means a worse outcome)'}, {'measure': 'Change in the monitoring of tissue oxygen pressure (PtiO2)', 'timeFrame': 'Change between day 0, 5, 9 after Intracranial Hemorrhage', 'description': 'Monitoring of tissue oxygen pressure (PtiO2)'}, {'measure': 'Change in the number of new ischemic lesions', 'timeFrame': 'Change between day 0, 5, 9, 21 after Intracranial Hemorrhage', 'description': 'Number of new ischemic lesions on non-contrast CT scan'}, {'measure': 'modified Rankin Scale at 3 months', 'timeFrame': '3 months after Intracranial Hemorrhage', 'description': 'clinical evolution (mRS between 0 and 6, a higher score means a worse outcome)'}, {'measure': 'Change in brain hypoperfusion 3', 'timeFrame': 'Change between day 0, 5, 9 after Intracranial Hemorrhage', 'description': 'Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters TMax maps in seconds on CT and/or MR perfusion'}, {'measure': 'Change in brain hypoperfusion 4', 'timeFrame': 'Change between day 0, 5, 9 after Intracranial Hemorrhage', 'description': 'Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters Mean transit time on CT and/or MR perfusion in seconds'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aneurysm, Ruptured', 'Aneurysmal Subarachnoid Hemorrhage', 'Arteriovenous Malformations', 'Intracranial Aneurysm', 'Intracranial Hemorrhages']}, 'descriptionModule': {'briefSummary': 'The study is an observational prospective evaluation of an approved and unchanged clinical management, evaluating different diagnosis methods to assess brain perfusion in patients with an aneurysmal or AVM-related intracranial hemorrhage', 'detailedDescription': 'The study is a prospective description and evaluation of an approved and unchanged clinical management, evaluating already used different diagnosis methods to assess brain perfusion in patients with atraumatic (aneurysmal, AVM-related, unknown cause) intracranial hemorrhage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who fit the inclusion criteria (suffered a non-traumatic (aneurysmal, AVM-related, unknown cause) intracranial hemorrhage) will be included prospectively.\n\nThe deadline for data collection November, 2031 Data analysis will be performed when judged necessary by the investigators.', 'healthyVolunteers': False, 'eligibilityCriteria': "i. Inclusion Criteria\n\n1. Age ≥ 18 years\n2. Non-traumatic intracranial hemorrhage (subarachnoid hemorrhage secondary to a ruptured aneurysm or AVM, unknown cause, per procedural bleed)\n3. In case of ruptured aneurysm, AVM or other etiology : need to be secured with surgical clipping or endovascular intervention if judged possible\n4. No contra-indication to perfusion imaging\n5. Subject or legal representative is able and willing to give informed consent.\n\nii. Exclusion Criteria\n\n1. Traumatic intracranial hemorrhage\n2. Contra-indication to imaging or patient's refusal."}, 'identificationModule': {'nctId': 'NCT05276934', 'acronym': 'SAVEBRAINPWI', 'briefTitle': 'Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI)', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Prospective Assessment of Brain Imaging After Aneurysmal of AVM-related Intracranial Hemorrhage', 'orgStudyIdInfo': {'id': 'SRB2021298'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Evolution of brain imaging in Non-traumatic Intracranial Hemorrhage', 'description': "This study will use an established local protocol for DCI and intracranial arterial vasospastic stenosis screening, and follow-up to make sure that all patients have the same protocol and don't lose any chance of improvement and good outcome", 'interventionNames': ['Diagnostic Test: Brain computed tomography']}], 'interventions': [{'name': 'Brain computed tomography', 'type': 'DIAGNOSTIC_TEST', 'description': "This study will use an established local protocol for DCI and intracranial arterial vasospastic stenosis screening, and follow-up to make sure that all patients have the same protocol and don't lose any chance of improvement and good outcome : CT perfusion at different time intervals", 'armGroupLabels': ['Evolution of brain imaging in Non-traumatic Intracranial Hemorrhage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'CUB-Hôpital Erasme Service de la Recherche biomédicale', 'role': 'CONTACT', 'email': 'Service.Rech-biomed@erasme.ulb.ac.be', 'phone': '+32 (0) 2 555 83 51'}, {'name': 'Boris Lubicz, MD, PhD', 'role': 'CONTACT', 'email': 'Boris.Lubicz@erasme.ulb.ac.be', 'phone': '003225553998'}, {'name': 'Adrien Guenego, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Erasme Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Comite ethique hopital Erasme', 'role': 'CONTACT', 'email': 'comite.ethique@erasme.ulb.ac.be', 'phone': '003225553707'}, {'name': 'Boris Lubicz, MD, PhD', 'role': 'CONTACT', 'email': 'Boris.Lubicz@erasme.ulb.ac.be', 'phone': '003225553998'}], 'overallOfficials': [{'name': 'Adrien Guenego, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasme University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}