Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-05 @ 7:36 AM
Study NCT ID:
NCT02081820
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2014-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Admission HbA1C in Aneurysmal Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2014-02-28', 'studyFirstSubmitQcDate': '2014-03-05', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Rankin score', 'timeFrame': '6 month after discharge'}], 'secondaryOutcomes': [{'measure': 'Incidence of DCI related new infarction on discharge ct scan', 'timeFrame': 'at discharge, approx. 14-21days after admission', 'description': 'Incidence of new infarction on discharge ct scan not attributable to causes other then DCI.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hyperglycemia', 'aneurysmal subarachnoid hemorrhage', 'glycated hemoglobin', 'outcome', 'DCI'], 'conditions': ['Hyperglycemia', 'Aneurysmal Subarachnoid Hemorrhage']}, 'descriptionModule': {'briefSummary': 'In patients suffering from aneurysmal subarachnoid hemorrhage (aSAH), hyperglycemia is considered an adverse prognostic factor. Glycated hemoglobin (or HbA1c) can be measured to estimate the average plasma glucose concentration over prolonged periods of time, thus determination of glycated hemoglobin at admission after aSAH serves as an approximation of blood glucose levels in the weeks preceding aneurysm rupture. In this patient registry admission HbA1c, clinical course and neurological outcome after 6 month are recorded, to determine whether elevated blood glucose levels prior to aneurysm rupture influence the clinical course and patient outcome after aSAH.', 'detailedDescription': 'In patients suffering from aneurysmal subarachnoid hemorrhage (aSAH), hyperglycemia is considered an adverse prognostic factor. Glycated hemoglobin (or HbA1c) can be measured to estimate the average plasma glucose concentration over prolonged periods of time, thus determination of glycated hemoglobin at admission after aSAH serves as an approximation of blood glucose levels in the weeks preceding aneurysm rupture.\n\nIn this patient registry admission HbA1c within 72 hours after confirmed aneurysmal subarachnoid hemorrhage in patients aged over 18 years is determined and correlated with clinical course and neurological outcome after 6 month as determined by modified Rankin score. Additionally, patients are monitored for incidence of delayed cerebral ischemia (DCI) and the incidence of new infarction on the discharge ct scan attributable to DCI. General treatment of cerebral aneurysm and subarachnoid hemorrhage in all patients follows international guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with confirmed aneurysmal subarachnoid hemorrhage admitted within 72 hours to our department aged over 18 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed aneurysmal subarachnoid hemorrhage\n* admission within 72hours after hemorrhage\n* Age \\>18 years\n\nExclusion Criteria:\n\n* non-aneurysmal SAH\n* admission \\>72hours after hemorrhage\n* Age \\<18 years'}, 'identificationModule': {'nctId': 'NCT02081820', 'briefTitle': 'Admission HbA1C in Aneurysmal Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Observational Study on the Prognostic Relevance of Admission Glycated Hemoglobin (HbA1C) in Patients With Aneurysmal Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': 'UKD-NCH-2014-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'aneurysmal subarachnoid hemorrhage', 'description': 'observational, no intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Department of Neurosurgery, Heinrich-Heine-University Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Kerim Beseoglu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery, Heinrich-Heine-University, Düsseldorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurochirurgische Klinik, Universitätsklinikum Düsseldorf', 'investigatorFullName': 'Neurochirurgische Klinik, Universitätsklinikum Düsseldorf', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}