Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-30 @ 11:49 AM
Study NCT ID:
NCT04945603
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid 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': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-24', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Outcome', 'timeFrame': '6 months.', 'description': 'modified Rankin Scale'}, {'measure': 'Clinical Outcome', 'timeFrame': '12 months', 'description': 'modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead) with higher scores indicating increasing neurological disability.'}], 'secondaryOutcomes': [{'measure': 'Long-Term clinical outcome', 'timeFrame': '12-60 months', 'description': 'modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead)'}, {'measure': 'Delayed Cerebral Ischemia', 'timeFrame': 'onset-30 days', 'description': 'Delayed Cerebral Ischemia'}, {'measure': 'Rebleeding', 'timeFrame': 'onset-48hours', 'description': 'Rebleeding'}, {'measure': 'Treatment Complications', 'timeFrame': 'onset-1 week', 'description': 'Treatment Complications'}, {'measure': 'Decompressive Craniotomy', 'timeFrame': 'onset-3 weeks', 'description': 'Incidence, strategy (primary or secondary), predictors and clinical impact'}, {'measure': 'Ventriculo-peritoneal shunt', 'timeFrame': 'onset-4 weeks', 'description': 'Incidence, strategy (primary or secondary), predictors and clinical impact'}, {'measure': 'CSF drainage', 'timeFrame': 'onset-3 weeks', 'description': 'Use of external ventricular drainage or lumbar drainage according to institutional protocol. Clinical impact.'}, {'measure': 'Volumetric analysis of intracranial bleeding', 'timeFrame': 'onset-24hours', 'description': 'Volumetric analysis and distribution assessment of intracranial bleeding. Clinical impact'}, {'measure': 'Volumetric analysis of delayed cerebral ischemia', 'timeFrame': 'onset-3 weeks', 'description': 'Volumetric analysis and location assessment of delayed cerebral ischemia. Clinical impact'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subarachnoid Hemorrhage, Aneurysmal', 'Poor Grade Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '37732736', 'type': 'BACKGROUND', 'citation': 'Panni P, Ambrosi A; POGASH (Poor Grade Aneurysmal Subarachnoid Hemorrhage) Investigators. In Reply: Clinical Impact and Predictors of Aneurysmal Rebleeding in Poor-Grade Subarachnoid Hemorrhage: Results From the National POGASH Registry. Neurosurgery. 2023 Dec 1;93(6):e174-e176. doi: 10.1227/neu.0000000000002691. Epub 2023 Sep 21. No abstract available.'}, {'pmid': '37010298', 'type': 'RESULT', 'citation': 'Panni P, Riccio L, Cao R, Pedicelli A, Marchese E, Caricato A, Feletti A, Testa M, Zanatta P, Gitti N, Piva S, Mardighian D, Semeraro V, Nardin G, Lozupone E, Paiano G, Picetti E, Montanaro V, Petranca M, Bortolotti C, Scibilia A, Cirillo L, Lanterna AL, Ambrosi A, Mortini P, Beretta L, Falini A. Clinical Impact and Predictors of Aneurysmal Rebleeding in Poor-Grade Subarachnoid Hemorrhage: Results From the National POGASH Registry. Neurosurgery. 2023 Sep 1;93(3):636-645. doi: 10.1227/neu.0000000000002467. Epub 2023 Apr 3.'}]}, 'descriptionModule': {'briefSummary': 'Multicentric registry study in order to define outcome, predictors, treatment effects and their modifiers in poor grade aneurysmal subarachnoid haemorrhage patients.\n\nThe search for outcome predictors is going to be subdivided into three main research areas:\n\n1. outcome predictors in the emergency department (so called "early brain injury phase").\n2. outcome predictors in the neurocritical care unit (so called "delayed brain injury phase").\n3. Treatment strategies. Two other areas of research are identified: delayed cerebral ischemia (incidence, treatment, predictors, impact on outcome) and long term follow-up (recent evidences suggest that there may be a non-negligible proportion of poor grade subarachnoid hemorrhage patients who may benefit from substantial improvement at long-term (after 6-12 months of follow-up).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients admitted to the emergency department because of aneurysmal subarachnoid hemorrhage of poor grade (IV-V) according to the WFNS classification', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the emergency department because of aneurysmal subarachnoid hemorrhage of poor grade (IV-V) according to the WFNS classification.\n\nExclusion Criteria:\n\n* Patients younger than 18 years old.\n* Pregnant or breast-feeding patients.\n* Aneurysmal subarachnoid hemorrhage due to trauma or vascular malformations other than cerebral aneurysms.'}, 'identificationModule': {'nctId': 'NCT04945603', 'acronym': 'POGASH', 'briefTitle': 'Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Poor Grade Aneurysmal Subarachnoid Hemorrhage Multicentric Study Group', 'orgStudyIdInfo': {'id': 'POGASH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Poor Grade Subarachnoid Hemorrhage', 'description': 'All patients (prospective and retrospective) included will have to present a subarachnoid hemorrhage defined poor grade according to the WFNS scale due to the rupture of an intracranial aneurysm.\n\nThe patients are managed according to both most recent international guidelines on the specific disease (Stroke, May 2012) and according to national and institutional guidelines/protocols.', 'interventionNames': ['Other: Standard management according to international/national guidelines']}], 'interventions': [{'name': 'Standard management according to international/national guidelines', 'type': 'OTHER', 'description': 'Standard management according to international/national guidelines. Observational study', 'armGroupLabels': ['Poor Grade Subarachnoid Hemorrhage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24127', 'city': 'Bergamo', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'ASST Ospedale Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo Bortolotti, MD', 'role': 'CONTACT', 'email': 'carlo.bortolotti@isnb.it'}], 'facility': 'IRCCS Bellaria', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '25123', 'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simone Piva, MD', 'role': 'CONTACT', 'email': 'simone.piva@unibs.it'}], 'facility': 'Azienda Ospedaliera Spedali Civili', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '73100', 'city': 'Lecce', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emilio Lozupone, MD', 'role': 'CONTACT', 'email': 'emilio.lozupone@gmail.com'}], 'facility': 'Ospedale Vito Fazzi', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'zip': '20134', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pietro Panni, P.I./MD', 'role': 'CONTACT', 'email': 'panni.pietro@hsr.it', 'phone': '+393406311389'}], 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Novara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rosanna Vaschetto, MD, PhD', 'role': 'CONTACT', 'email': 'rosanna.vaschetto@med.uniupo.it'}, {'name': 'Rosanna Vaschetto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Maggiore della Città di Novara', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '43126', 'city': 'Parma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Edoardo Picetti, MD', 'role': 'CONTACT', 'email': 'edoardopicetti@hotmail.it'}], 'facility': 'Azienda Ospedaliero-Universitaria di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '00168', 'city': 'Roma', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Policlinico Universitario Agostino Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '74121', 'city': 'Taranto', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vittorio Semeraro, MD', 'role': 'CONTACT', 'email': 'vittoriosemeraro@hotmail.it'}], 'facility': 'Ospedale Santissima Annunziata', 'geoPoint': {'lat': 40.46438, 'lon': 17.24707}}, {'zip': '37126', 'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alberto Feletti, Professor/MD', 'role': 'CONTACT', 'email': 'alberto.feletti@univr.it'}], 'facility': 'Azienda Ospedaliera Universitaria Integrata', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Pietro Panni, P.I., M.D.', 'role': 'CONTACT', 'email': 'panni.pietro@hsr.it', 'phone': '+393406311389'}, {'name': 'Andrea Falini, Professor of Neuroradiology', 'role': 'CONTACT', 'email': 'falini.andrea@hsr.it', 'phone': '+39 0226432239'}], 'overallOfficials': [{'name': 'Pietro Panni, P.I., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neuroradiology, Department of Neurosurgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliera Universitaria Integrata Verona', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliero-Universitaria di Parma', 'class': 'OTHER'}, {'name': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia', 'class': 'OTHER'}, {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, {'name': 'A.O. Ospedale Papa Giovanni XXIII', 'class': 'OTHER'}, {'name': 'ASL Taranto', 'class': 'OTHER'}, {'name': 'Ospedale V. Fazzi', 'class': 'OTHER'}, {'name': 'IRCCS Istituto delle Scienze Neurologiche di Bologna', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliero Universitaria Maggiore della Carita', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pietro Panni', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}