Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-06 @ 10:02 AM
Study NCT ID:
NCT03822260
Status:
UNKNOWN
Last Update Posted:
2019-01-30
First Post:
2018-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Neuroinflamation of SAH
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "In the blood plasma stored in the temperature of -86 'C for the period not longer than 6 months, the concentration of the following parameters was marked with the use of immunoenzymatic ELISA method"}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2018-11-12', 'studyFirstSubmitQcDate': '2019-01-28', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic marker identification', 'timeFrame': '24 months', 'description': 'Evaluation of the concentration levels of enflamation markers relation with Sur1 TRPM+ molecules, together with the values of global tests of coagulation system, may serve as a helpful SAH diagnostic marker.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subarachnoid Hemorrhage, Aneurysmal']}, 'descriptionModule': {'briefSummary': "The investigators are planning that can these markers be used a predictive marker at SAH and for this aim we will study both patiens' blood sample and their CT image.", 'detailedDescription': "An ideal marker which could be used clinically should meet numerous criteria, such as high sensitivity or the possibility of easy and quick assessment of its concentration in blood or blood plasma.The Fisher's scale presents an alternative for evaluating patients with subarachnoid hemorrhage . The investigator are going to evaluate both plasma markers and fishers scale at SAH."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to the emergency room of the universty hospital with aSAH have a CBC and blood sample performed on admission. Blood samples are obtained significant days (1,4-14 days) thereafter during their hospitalization.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ruptured Subarachnoid Aneursym\n\nExclusion Criteria:\n\n* without aneursymal sah\n* Patient's positive for rheumatoid factor and anti-CCP or with chronic inflammatory diseases (such as ankylosing spondylitis or rheumatoid arthritis), systemic diseases (such as hypercholesterolemia, hypertension, diabetes mellitus, myocardial infarction, stroke, peripheral artery disease), active infection, a history of term medication, trauma to the hip and smoking were excluded from the study."}, 'identificationModule': {'nctId': 'NCT03822260', 'acronym': 'BAP', 'briefTitle': 'Evaluation of Neuroinflamation of SAH', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Comparasion of Bio-markers and Neuroimaging Changes Caused by Neuroenflamation After the Aneurysmal Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': 'TD -001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sur1/ Trpm 4 acitivities at SAH', 'description': 'only after collecting sample,', 'interventionNames': ['Diagnostic Test: Bezmialem VAkif Unv. Ethical board']}], 'interventions': [{'name': 'Bezmialem VAkif Unv. Ethical board', 'type': 'DIAGNOSTIC_TEST', 'description': 'If ıs any trials not convenient to Helsinki Agrement about Human research rules', 'armGroupLabels': ['Sur1/ Trpm 4 acitivities at SAH']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'ıt was not decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}