[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415967":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":130,"collaborators":133,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":139,"sex":145,"minAge":146,"maxAge":26,"enrollmentInfo":147,"targetDuration":26,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":161,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Turku University Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Air\u002FOxygen","ACTIVE_COMPARATOR","Control arm: air\u002Foxygen with standard of care",[13],"Drug: air\u002Foxygen",{"label":15,"type":16,"description":17,"interventionNames":18},"xenon","EXPERIMENTAL","Xenon arm: xenon inhalation in air\u002Foxygen with standard of care",[19],"Drug: Xenon",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Xenon","Xenon arm will be treated with xenon inhalation with endtidal concentration of 50 % in air\u002Foxygen and with standard of care",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"air\u002Foxygen","Control group will be treated with air\u002Foxygen",[9],[32],{"name":33,"affiliation":34,"role":35},"Timo T Laitio, MD, PhD","Turku University Hospital and University of Turku, Turku , Finland","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+358504653201","timo.laitio@tyks.fi",[42,58,70,83,95,104,116],{"facility":43,"status":44,"city":45,"state":45,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Aalto University School of Science","NOT_YET_RECRUITING","Helsinki","Finland","FI",{"type":49,"coordinates":50},"Point",[51,52],24.93545,60.16952,{"lat":52,"lon":51},[55],{"name":56,"role":38,"phone":26,"phoneExt":26,"email":57},"Timo Roine, PhD","timo.roine@gmail.com",{"facility":59,"status":44,"city":60,"state":60,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Kuopio University Hospital","Kuopio",{"type":49,"coordinates":62},[63,64],27.67703,62.89238,{"lat":64,"lon":63},[67],{"name":68,"role":38,"phone":26,"phoneExt":26,"email":69},"Stepani Bendel","stepani.bendel@kuh.fi",{"facility":71,"status":44,"city":72,"state":73,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Tampere University Hospital","Tampere","Pirkanmaa",{"type":49,"coordinates":75},[76,77],23.78712,61.49911,{"lat":77,"lon":76},[80],{"name":81,"role":38,"phone":26,"phoneExt":26,"email":82},"Sari Karlsson, MD, PhD","sari.karlsson@pshp.fi",{"facility":5,"status":84,"city":85,"state":85,"zip":86,"country":46,"countryCode":47,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"RECRUITING","Turku","20521",{"type":49,"coordinates":88},[89,90],22.26869,60.45148,{"lat":90,"lon":89},[93],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":94},"timo.laitio@varha.fi",{"facility":96,"status":44,"city":85,"state":85,"zip":97,"country":46,"countryCode":47,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"Elomatic","20810",{"type":49,"coordinates":99},[89,90],{"lat":90,"lon":89},[102],{"name":103,"role":38,"phone":26,"phoneExt":26,"email":26},"Juha Tanttari, MSc",{"facility":105,"status":44,"city":85,"state":85,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":106,"geoPoint":108,"contacts":109},"University of Turku, Turku Bioscience, Analysis of the metabolomics",{"type":49,"coordinates":107},[89,90],{"lat":90,"lon":89},[110,113],{"name":111,"role":38,"phone":26,"phoneExt":26,"email":112},"Matej Orešič, PhD","matej.oresic@utu.fi",{"name":114,"role":38,"phone":26,"phoneExt":26,"email":115},"Alex Dickens, PhD","alex.dickens@utu.fi",{"facility":117,"status":44,"city":118,"state":119,"zip":26,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Örebro University","Örebro","Örebro County","Sweden","SE",{"type":49,"coordinates":123},[124,125],15.2066,59.27412,{"lat":125,"lon":124},[128],{"name":129,"role":38,"phone":26,"phoneExt":26,"email":26},"Tuulia Hyötyläinen, PhD",{"type":35,"investigatorFullName":131,"investigatorTitle":132,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Timo Laitio","associate professor, head physician",[134],{"name":135,"class":136},"Academy of Finland","OTHER","100415967","phase-2-effect-of-xenon-on-brain-injury-after-aneurysmal-subarachnoid-hemorrhage-100415967",false,"NCT04696523","Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage","Effect of Xenon on Brain Injury, Neurological Outcome and Survival in Patients After Aneurysmal Subarachnoid Hemorrhage","Xe-SAH","Inclusion Criteria:\n\nTo be considered eligible to participate in this study, a SAH subject must meet the inclusion criteria listed below:\n\n1. Informed consent obtained from the next of kin or legal representative\n2. Aneurysmal subarachnoid hemorrhage visible on CTA or DSA.\n3. Deterioration of consciousness to Hunt-Hess 3-5\n4. Age of ≥ 18 years\n5. Intubated.\n6. GCS 3-12 obtained off neuromuscular blocking agents\n7. Xenon treatment can be started within 6 hours after onset of SAH symptoms\n\nExclusion Criteria:\n\nAn aSAH subject may not be enrolled in the trial if he\u002Fshe meets any one of the exclusion criteria below:\n\n1. Acute or chronic traumatic brain injury\n2. Maximum diameter of intracerebral hemorrhage \\> 2.5 cm\n3. Pneumothorax or pneumomediastinum,\n4. Acute lung injury requiring ≥ 60% FIO2 (fraction of inspired oxygen).\n5. Systolic arterial pressure \\\u003C 80 mmHg or mean arterial pressure \\\u003C 60 mmHg for over 30 min period\n6. Bilaterally fixed and dilated pupils\n7. Positive pregnancy test, known pregnancy, or current breast-feeding\n8. Neurological deficiency due to traumatic brain injury or other neurological illness\n9. Imminent death or current life-threatening disease\n10. Current enrollment in another interventional study\n11. The subject is known to have clinically significant laboratory abnormality, medical condition (such as decompensated liver disease or severe chronic obstructive pulmonary disease), or social circumstance that, in the investigator's opinion, makes it inappropriate for the subject to participate in this clinical trial.\n12. Presence of implants or foreign bodies which are not known to be MRI safe","ALL","18 Years",{"count":148,"type":149},160,"ESTIMATED","INTERVENTIONAL",[152],"PHASE2","An investigator-initiated clinical drug study\n\nMain Objective:\n\nTo explore neuroprotective properties of xenon in patients after aneurysmal subarachnoid hemorrhage (SAH).\n\nPrimary endpoint: Global fractional anisotropy of white matter of diffusion tensor imaging (DTI). Hypothesis: White matter damage is less severe in xenon treated patients, i.e. global fractional anisotropy is significantly higher in the xenon group than in the control group as assessed with the 1st magnetic resonance imaging (MRI).\n\nAfter confirmation of aSAH and obtaining a signed assent subjects will be randomized to the following groups:\n\nControl group: Standard of Care (SOC) group: Air\u002Foxygen and Normothermia 36.5-37.5°C; Xenon group: Normothermia 36.5-37.5°C +Xenon inhalation in air\u002Foxygen for 24 hours. Brain magnetic resonance imaging techniques will be undertaken to evaluate the effects of the intervention on white and grey matter damage and neuronal loss. Neurological outcome will be evaluated at 3, 12 and 24 months after onset of aSAH symptoms Investigational drug\u002Ftreatment, dose and mode of administration: 50±2 % end tidal concentration of inhaled xenon in oxygen\u002Fair.\n\nComparative drug(s)\u002Fplacebo\u002Ftreatment, dose and mode of administration: Standard of care treatment according to local and international consensus reports.\n\nDuration of treatment: 24 hours\n\nAssessments:\n\nBaseline data Information that characterizes the participant's condition prior to initiation of experimental treatment is obtained as soon as is clinically reasonable. These include participant demographics, medical history, vital signs, oxygen saturation, and concentration of oxygen administered.\n\nAcute data The collected information will contain quantitative and qualitative data of aSAH patients, as recommended by recent recommendations of the working group on subject characteristics, and including all relevant Common Data Elements (CDE) can be applied. Specific definitions, measurements tools, and references regarding each SAH CDE can be found on the weblink here: https:\u002F\u002Fwww.commondataelements.ninds.nih.gov\u002FSAH.aspx#tab=Data\\_Standards.",[155,156,157,158,159,160],"Subarachnoid Hemorrhage, Aneurysmal","Cerebral Injury","Cerebral Ischemia","Cerebral Infarction","Cardiac Event","Cardiac Failure",[162],"xenon, neuroprotection, aneurysmal subarachnoid hemorrhage","2025-04-28",{"date":165,"type":166},"2025-05-01","ACTUAL",{"date":168,"type":166},"2025-04-22",{"date":170,"type":149},"2029-12-31",{"name":5,"class":6},7]