{
  "FullStudy":{
    "Rank":217800,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516671",
          "OrgStudyIdInfo":{
            "OrgStudyId":"LMU-XX2011"
          },
          "Organization":{
            "OrgFullName":"Ludwig-Maximilians - University of Munich",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Neuroinflammation and Bispectral Index After Subarachnoid Hemorrhage",
          "OfficialTitle":"Pilot Study on the Role of Neuroinflammation in the Pathophysiology of Subarachnoid Hemorrhage and the Value of the Bilateral Bispectral Index for Early Diagnosis of Cerebral Ischemia After Subarachnoid Hemorrhage."
        },
        "StatusModule":{
          "StatusVerifiedDate":"November 2013",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2013",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2013",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"November 11, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 13, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Cyrill Hornuss",
            "ResponsiblePartyInvestigatorTitle":"Study Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"Ludwig-Maximilians - University of Munich"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Ludwig-Maximilians - University of Munich",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Subarachnoid hemorrhage (SAH) is associated with a high mortality and frequently leads to severe disability in survivors caused by cerebral vasospasm and infarction.\n\nThis study aims to elucidate the role of neuroinflammation (endocannabinoids and cortisol levels in cerebrospinal fluid) in the pathophysiology of cerebral vasospasm and the value of the bilateral bispectral index (BIS) for the early diagnosis of cerebral vasospasm.",
          "DetailedDescription":"Subarachnoid hemorrhage (SAH) or bleeding in the brain is a form of stroke. SAH mostly results from ruptured aneurysms. This severe disease often results in death or severe physical or cognitive disabilities and reduced quality of life. One frequent complication after SAH is cerebral vasospasm, a spasm of the big arteries accompanied by infarction of healthy brain tissue. The pathophysiologic processes which drive vasospasm remain unclear. This study aims to examine the role of endocannabinoids and cortisol in cerebrospinal fluid during the development of cerebral vasospasm. Additionally, this study examines whether side difference in the processed electroencephalogram (bilateral bispectral index) may be useful for early detection of cerebral vasospasm."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Subarachnoid Hemorrhage"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Subarachnoid hemorrhage",
              "Cerebral vasospasm",
              "Neuroinflammation",
              "Bilateral Bispectral Index"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"Cerebrospinal fluid Blood"
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"40",
            "EnrollmentType":"Anticipated"
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Concentrations of endocannabinoids and corticoids in cerebrospinal fluid and blood.",
                "PrimaryOutcomeDescription":"Samples of cerebrospinal fluid and blood will be collected every day at 8am on hospital day 1-14 and the concentrations of the following substances will be determined:\n\nAnandamide\n2-arachidonoylglycerol\n2-arachidonoylglycerol-ether\nN-arachidonoyldopamine\nN-arachidonylglycine\nO-arachidonylethanolamide\nPalmitoylethanolamide\nCortisol\nCorticotropin-releasing hormone (in CSF only)\nCorticosteroid-binding globulin (in blood only)",
                "PrimaryOutcomeTimeFrame":"Once per day from day 1 until day 14 after hospital admission"
              },{
                "PrimaryOutcomeMeasure":"Bilateral Bispectral Index",
                "PrimaryOutcomeDescription":"The Bispectral Index is calculated every second by the BIS Vista monitor. These data will be recorded continuously from 0:01 am until 23:59 pm.",
                "PrimaryOutcomeTimeFrame":"Every second from 0:01 am until 23:59 pm on hospital day 1,2,3,4,5,6,7,8,9,10,11,12,13,14"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Transcranial Doppler",
                "SecondaryOutcomeDescription":"The mean velocities in middle cerebral and anterior cerebral arteries will be determined by transcranial Doppler",
                "SecondaryOutcomeTimeFrame":"Every day at 8 am from day 1 until day 14 after hospital admission"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAdmission to neurosurgical ICU Klinikum der Universität München\nSAH\nExternal CSF drainage\n\nExclusion Criteria:\n\n- AGE < 18",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Patients after acute SAH admitted to neurosurgical ICU",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Volker Huge, MD",
                "OverallOfficialAffiliation":"Klinikum der Universität München, Ludwig-Maximilians-University, Department of Anaesthesiology",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Cyrill Hornuss, MD",
                "OverallOfficialAffiliation":"Klinikum der Universität München, Ludwig-Maximilians-University, Department of Anaesthesiology",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Klinikum der Universität München",
                "LocationCity":"München",
                "LocationZip":"81377",
                "LocationCountry":"Germany"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"19576247",
                "ReferenceType":"background",
                "ReferenceCitation":"Altay T, Smithason S, Volokh N, Rasmussen PA, Ransohoff RM, Provencio JJ. A novel method for subarachnoid hemorrhage to induce vasospasm in mice. J Neurosci Methods. 2009 Oct 15;183(2):136-40. doi: 10.1016/j.jneumeth.2009.06.027. Epub 2009 Jul 1."
              },{
                "ReferencePMID":"21559525",
                "ReferenceType":"background",
                "ReferenceCitation":"Huge V, Lauchart M, Magerl W, Beyer A, Moehnle P, Kaufhold W, Schelling G, Azad SC. Complex interaction of sensory and motor signs and symptoms in chronic CRPS. PLoS One. 2011 Apr 29;6(4):e18775. doi: 10.1371/journal.pone.0018775."
              },{
                "ReferencePMID":"18648647",
                "ReferenceType":"background",
                "ReferenceCitation":"Huge V, Lauchart M, Förderreuther S, Kaufhold W, Valet M, Azad SC, Beyer A, Magerl W. Interaction of hyperalgesia and sensory loss in complex regional pain syndrome type I (CRPS I). PLoS One. 2008 Jul 23;3(7):e2742. doi: 10.1371/journal.pone.0002742."
              },{
                "ReferencePMID":"21059474",
                "ReferenceType":"background",
                "ReferenceCitation":"Provencio JJ, Altay T, Smithason S, Moore SK, Ransohoff RM. Depletion of Ly6G/C(+) cells ameliorates delayed cerebral vasospasm in subarachnoid hemorrhage. J Neuroimmunol. 2011 Mar;232(1-2):94-100. doi: 10.1016/j.jneuroim.2010.10.016. Epub 2010 Nov 6."
              },{
                "ReferencePMID":"16099244",
                "ReferenceType":"background",
                "ReferenceCitation":"Lin CL, Dumont AS, Calisaneller T, Kwan AL, Hwong SL, Lee KS. Monoclonal antibody against E selectin attenuates subarachnoid hemorrhage-induced cerebral vasospasm. Surg Neurol. 2005 Sep;64(3):201-5; discussion 205-6."
              },{
                "ReferencePMID":"18781977",
                "ReferenceType":"background",
                "ReferenceCitation":"Wolf SA, Tauber S, Ullrich O. CNS immune surveillance and neuroinflammation: endocannabinoids keep control. Curr Pharm Des. 2008;14(23):2266-78. Review."
              },{
                "ReferencePMID":"17555867",
                "ReferenceType":"background",
                "ReferenceCitation":"Tischner D, Reichardt HM. Glucocorticoids in the control of neuroinflammation. Mol Cell Endocrinol. 2007 Sep 15;275(1-2):62-70. Epub 2007 May 4. Review."
              },{
                "ReferencePMID":"19509383",
                "ReferenceType":"background",
                "ReferenceCitation":"Annane D, Bellissant E, Bollaert PE, Briegel J, Confalonieri M, De Gaudio R, Keh D, Kupfer Y, Oppert M, Meduri GU. Corticosteroids in the treatment of severe sepsis and septic shock in adults: a systematic review. JAMA. 2009 Jun 10;301(22):2362-75. doi: 10.1001/jama.2009.815. Review."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000013345",
                "ConditionMeshTerm":"Subarachnoid Hemorrhage"
              },{
                "ConditionMeshId":"D000006470",
                "ConditionMeshTerm":"Hemorrhage"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000020300",
                "ConditionAncestorTerm":"Intracranial Hemorrhages"
              },{
                "ConditionAncestorId":"D000002561",
                "ConditionAncestorTerm":"Cerebrovascular Disorders"
              },{
                "ConditionAncestorId":"D000001927",
                "ConditionAncestorTerm":"Brain Diseases"
              },{
                "ConditionAncestorId":"D000002493",
                "ConditionAncestorTerm":"Central Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000014652",
                "ConditionAncestorTerm":"Vascular Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8139",
                "ConditionBrowseLeafName":"Hemorrhage",
                "ConditionBrowseLeafAsFound":"Hemorrhage",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9126",
                "ConditionBrowseLeafName":"Ischemia",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14718",
                "ConditionBrowseLeafName":"Subarachnoid Hemorrhage",
                "ConditionBrowseLeafAsFound":"Subarachnoid Hemorrhage",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M4376",
                "ConditionBrowseLeafName":"Cerebral Infarction",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20697",
                "ConditionBrowseLeafName":"Intracranial Hemorrhages",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4393",
                "ConditionBrowseLeafName":"Cerebrovascular Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3786",
                "ConditionBrowseLeafName":"Brain Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4325",
                "ConditionBrowseLeafName":"Central Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15983",
                "ConditionBrowseLeafName":"Vascular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              }
            ]
          }
        }
      }
    }
  }
}