[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cerebral-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cerebral-injury":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32],"Subarachnoid Hemorrhage, Aneurysmal","Cerebral Injury","Cerebral Ischemia","Cerebral Infarction","Cardiac Event","Cardiac Failure",[34],"xenon, neuroprotection, aneurysmal subarachnoid hemorrhage","RECRUITING","2025-04-28",{"date":38,"type":39},"2025-05-01","ACTUAL",{"date":41,"type":39},"2025-04-22",{"date":43,"type":21},"2029-12-31",{"name":45,"class":46},"Turku University Hospital","OTHER_GOV",7,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100562749","cerebral-hypoperfusion-at-transcranial-color-coded-doppler-100562749","NCT06607211","Cerebral Hypoperfusion at Transcranial Color-Coded Doppler.","Cerebral Hypoperfusion at Transcranial Color-Coded Doppler. Effects of a Treatment Protocol in Patients With Acute Brain Injury","IPOPERT","Inclusion Criteria:\n\n* Age over 18 years\n* Patients with intraparenchymal cerebral hemorrhage, subarachnoid hemorrhage, head trauma, or hydrocephalus\n* Glasgow Coma Scale belowe 9\n* Need for invasive mechanical ventilation\n* Arterial catheter for invasive blood pressure monitoring and blood sampling\n* Presence of Doppler parameters of cerebral hypoperfusion (concurrent presence of two or more of the following conditions: PI \\> 1.4, diastolic velocity \\\u003C 20 cm\u002Fs, and mean velocity \\\u003C 30 cm\u002Fs detected in at least one middle cerebral artery)\n\nExclusion Criteria:\n\n* Absence of transtemporal windows bilaterally on TCCD\n* Documented severe aortic valve insufficiency\n* Heart rate less than 40 bpm\n* Patients with suspected vasospasm on TCCD",{"count":57,"type":21},100,"OBSERVATIONAL","Background. Cerebral ischemia is a major secondary factor contributing to worsening outcomes in patients with acute brain injuries. Transcranial Color-Coded Doppler (TCCD) is a reliable method for evaluating cerebral perfusion and is recommended for use in emergency settings to reduce secondary injuries. However, there is no established treatment protocol for managing cerebral hypoperfusion as detected by TCCD.\n\nObjective. The primary objective of this study is to assess the efficacy of individual steps in a standardized treatment protocol to normalize TCCD parameters in patients with cerebral hypoperfusion. The secondary objective is to investigate the concordance between invasive intracranial pressure (ICP) measurements and those estimated through TCCD using the Czosnyka formula.\n\nMethods. This prospective multicenter observational study will enroll patients with acute brain injury admitted in emergency or intensive care settings. Inclusion criteria include age over 18, Glasgow Coma Scale \\\u003C9, and evidence of cerebral hypoperfusion based on TCCD performed on M1 tract of at least one middle cerebral artery. The hypoperfusion is defined as the concurrent presence of at least two of the following parameters: mean velocity below 30 cm\u002Fs, diastolic velocity below 20 cm\u002Fs, pulsatility index above 1.4.\n\nPatients will undergo a stepwise treatment approach involving normocapnia verification, autoregulation testing increasing mean arterial pressure by 10 mmHg, and hyperosmolar therapy. The effectiveness of each intervention will be assessed by TCCD readings.\n\nEndpoints. The primary endpoint is the percentage of patients who normalize cerebral perfusion parameters at each step of the protocol. The secondary endpoint is the concordance between invasive ICP measurements and those estimated through TCCD.\n\nSample Size. The study aims to recruit 100 patients over 24 months. Data analysis will include descriptive statistics, with significant results considered at p \\\u003C 0.05.",[28],"NOT_YET_RECRUITING","2024-09-19",{"date":64,"type":39},"2024-09-23",{"date":66,"type":21},"2024-10-01",{"date":68,"type":21},"2026-03-31",{"name":70,"class":71},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":72},"100406593","functional-near-infrared-spectroscopy-in-adult-surgery-100406593","NCT04574440","Functional Near Infrared Spectroscopy in Adult Surgery","Evaluation of Cerebral Oxygenation Using Functional Near Infrared Spectroscopy in Adult Surgery","Inclusion Criteria:\n\n* Adult cardiac surgery patients who are scheduled to have elective cardiac operations.\n\nExclusion Criteria:\n\n* Under 18 years of age\n* have skin lesions or other conditions that preclude the application of fNIRS to the head\n* lack of written consent\n* emergency surgery",{"count":81,"type":21},40,"Brain injury is a serious problem after cardiac surgery. Brain injury can become evident in the form of stroke and cognitive dysfunction after surgery. The current neuromonitoring technique used is unable to monitor the region of the brain that is most susceptible to injury. This study aims to use a novel, non-invasive brain monitoring technique known as multichannel functional near infrared spectroscopy to assess brain oxygenation at multiple brain regions simultaneously during cardiac surgery. This research enables the investigators to understand the differences between regional brain oxygenation during cardiac surgery and to assess the feasibility and effectiveness of multichannel functional near infrared spectroscopy to be used as a future brain monitoring technique to detect brain injury in cardiac surgery.",[28],[85,86,87],"multichannel functional near infrared spectroscopy (fNIRS)","cerebral oxygenation","cardiac surgery","2024-06-03",{"date":90,"type":39},"2024-06-04",{"date":92,"type":39},"2019-12-20",{"date":94,"type":21},"2025-12-30",{"name":96,"class":71},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"]