Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT02334657
Status:
COMPLETED
Last Update Posted:
2016-05-04
First Post:
2015-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of Long-term Outcome After Non-aneurysmal Subarachnoid Hemorrhage
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'targetDuration': '15 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-03', 'studyFirstSubmitDate': '2015-01-06', 'studyFirstSubmitQcDate': '2015-01-06', 'lastUpdatePostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36', 'timeFrame': '18months to 15 years', 'description': 'Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36 stratified to:\n\n* non-aneurysmal SAH\n* PM /NPM-SAH\n* mRS 0 group\n* NPM-SAH: Fisher 3 or non-Fisher 3 bleeding pattern'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '18months to 15 years', 'description': 'deaths until long-term follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['non-aneurysmal'], 'conditions': ['Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '26916565', 'type': 'DERIVED', 'citation': 'Konczalla J, Schmitz J, Kashefiolasl S, Senft C, Platz J, Seifert V. Non-aneurysmal non-perimesencephalic subarachnoid hemorrhage: effect of rehabilitation at short-term and in a prospective study of long-term follow-up. Top Stroke Rehabil. 2016 Aug;23(4):261-8. doi: 10.1080/10749357.2016.1149982. Epub 2016 Mar 15.'}, {'pmid': '26130053', 'type': 'DERIVED', 'citation': 'Konczalla J, Schmitz J, Kashefiolasl S, Senft C, Seifert V, Platz J. Non-aneurysmal subarachnoid hemorrhage in 173 patients: a prospective study of long-term outcome. Eur J Neurol. 2015 Oct;22(10):1329-36. doi: 10.1111/ene.12762. Epub 2015 Jul 1.'}]}, 'descriptionModule': {'briefSummary': "Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source can be identified despite of repetitive radiological imaging. Patients, at least 18 months after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining the study purpose and the postal questionnaire consisting a short-form health survey with 36 simple questions. If we didn't receive answers after three months we made telephone interviews with the patients' family members or their general practitioner.", 'detailedDescription': "Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source can be identified despite of repetitive radiological imaging. The blood distribution can be described as perimesencephalic/prepontine or non-perimesencephalic. Depending on the pattern of SAH the clinical course of the patients can be similar to aneurysmal SAH. In general, patients with a perimesencephalic SAH (PM-SAH) are considered to achieve good outcome and to have lower rebleeding risk. However, long-term outcome data on patients suffering from spontaneous non-aneurysmal SAH (non-aSAH) is scarce and lacking for physical and psychological outcome. Therefore, the aim of the present study was to investigate the long-term physical and psychological outcome in patients suffering from non-aneurysmal spontaneous SAH.\n\nSAH was confirmed on computed tomography (CT) or lumbar puncture. Only patients with a non-traumatic SAH were included. In our hospital algorithm all patients with SAH underwent angiography including 3D digital subtraction angiography (DSA) since 2002 to rule out intracranial sources for SAH. In case of a negative initial angiography, DSA was repeated after 14 days. Additionally, magnetic resonance imaging (MRI) of head/spine was performed to rule out any spinal bleeding sources. In patients with blood distribution exceeding the typical perimesencephalic pattern, a third DSA was performed 3 months after SAH. The first (short-term) follow-up (F/U) was performed six months after ictus. Outcome was measured according to the modified Rankin Scale (mRS) and stratified into favorable (mRS 0-2) and unfavorable (mRS 3-6) after six months. Patients with non-aSAH were divided into perimesencephalic SAH (PM-SAH), non-perimesencephalic SAH (NPM-SAH) and excellent Outcome group (mRS 0). Also the NPM-SAH group was further stratified into Fisher 3 blood pattern and NPM-SAH without Fisher 3 blood pattern.\n\nPatients, at least 18 months after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining the study purpose and the postal questionnaire consisting a short-form health survey with 36 simple questions. If we didn't receive answers after three months we made telephone interviews with the patients' family members or their general practitioner."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a spontaneous, non-traumatic SAH, in whom no bleeding source was identified by repetitive angiography including 3D digital subtraction angiography', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* spontaneous, non-traumatic SAH\n* SAH confirmed on computed tomography (CT) or lumbar puncture\n* negative initial and follow-up angiography\n* age: no limit\n\nExclusion Criteria:\n\n* traumatic SAH\n* aneurysmal SAH\n* SAH in whom other bleeding sources were identified (AVM etc.)'}, 'identificationModule': {'nctId': 'NCT02334657', 'briefTitle': 'Prospective Study of Long-term Outcome After Non-aneurysmal Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'University Clinic Frankfurt'}, 'officialTitle': 'Prospective Study of Long-term Outcome After Non-aneurysmal Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': '109/13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-aneurysmal subarachnoid hemorrhage', 'description': 'patients with non-aneurysmal subarachnoid hemorrhage, short-term outcome measured by modified Rankin Scale and long-term outcome by SF-36', 'interventionNames': ['Other: SF-36']}, {'label': 'perimesencephalic SAH', 'description': 'subgroup of non-aneurysmal subarachnoid hemorrhage', 'interventionNames': ['Other: SF-36']}, {'label': 'non-perimesencephalic (NPM) SAH', 'description': 'subgroup of non-aneurysmal subarachnoid hemorrhage', 'interventionNames': ['Other: SF-36']}, {'label': 'subgroup of NPM-SAH with Fisher 3', 'description': 'patients with non-aneurysmal (non-perimesencephalic) SAH and a Fisher 3 bleeding pattern', 'interventionNames': ['Other: SF-36']}, {'label': 'subgroup of NPM-SAH w/o Fisher 3', 'description': 'patients with non-aneurysmal (non-perimesencephalic) SAH and not a Fisher 3 bleeding pattern', 'interventionNames': ['Other: SF-36']}], 'interventions': [{'name': 'SF-36', 'type': 'OTHER', 'description': 'postal questionnaire consisting a short-form health survey with 36 simple questions (SF-36)', 'armGroupLabels': ['non-aneurysmal subarachnoid hemorrhage', 'non-perimesencephalic (NPM) SAH', 'perimesencephalic SAH', 'subgroup of NPM-SAH w/o Fisher 3', 'subgroup of NPM-SAH with Fisher 3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Juergen Konczalla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goethe University Hospital, Department of Neurosurgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Clinic Frankfurt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Juergen Konczalla', 'investigatorAffiliation': 'University Clinic Frankfurt'}}}}