[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446624":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":60,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":31,"enrollmentInfo":76,"targetDuration":31,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":47,"whyStopped":31,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"S-ketamine","ACTIVE_COMPARATOR","S-ketamine is given as a continuous infusion started at a dose of 2.0 mg\u002Fkg\u002Fhour. The infusion rate will be re-evaluated after 24 hours, where (1) the infusion will be stopped if 24 hours ensue without SDs, (2) maintained at 2.0 mg\u002Fkg\u002Fhour if the 24-hour incidence of SDs decreases below the rate of the previous 24 hours but SD is not totally abolished, or (3) increased to 3.0 mg\u002Fkg\u002Fhour if the incidence of SD is at or above the rate of the previous 24 hours. If the infusion rate has been increased to 3.0 mg\u002Fkg\u002Fhour, the rate will be returned to 2.0 mg\u002Fkg\u002Fhour if 24 consecutive hours of ECoG show no SD.",[13],"Drug: S-ketamine",{"label":15,"type":16,"description":17,"interventionNames":18},"Isotonic saline","PLACEBO_COMPARATOR","Isotonic saline is given as placebo. It will be given as a continuous infusion started at a dose corresponding to a dose of S-ketamine of 2.0 mg\u002Fkg\u002Fhour, and follow the criteria for increasing\u002Fdecreasing infusion rates as S-ketamine. The infusion rate is read from a table listing different infusion rates (ml\u002Fhour) based on participant weight and if the treatment tier corresponds to a S-ketamine dose of 2 or 3 mg\u002Fkg\u002Fhour.",[19],"Other: Isotonic saline (placebo)",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","S-ketamines is an NMDA-receptor antagonist with sedative and analgesic properties. It will in the present trial be given in sedative doses (2-3 mg\u002Fkg\u002Fhour) in case of clustered SDs following a dosing algorithm according to SD occurrence.",[9],[26],"Esketamine",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Isotonic saline (placebo)","Isotonic saline has the same appearance as S-ketamine with both being clear liquids with no bubbles or other distinguishing features.",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Trine H Andreasen, MD","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":31,"email":40},"CONTACT","+4535455982","trine.hjorslev.andreasen@regionh.dk",{"name":42,"role":38,"phone":31,"phoneExt":31,"email":43},"Kirsten Møller, Professor","Kirsten.Moeller.01@regionh.dk",[45],{"facility":46,"status":47,"city":48,"state":31,"zip":31,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Rigshospitalet","RECRUITING","Copenhagen","Denmark","DK",{"type":52,"coordinates":53},"Point",[54,55],12.56553,55.67594,{"lat":55,"lon":54},[58],{"name":59,"role":38,"phone":31,"phoneExt":31,"email":40},"Trine Hjorslev Andreasen, M.D",{"type":35,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Trine Hjorslev Andreasen","MD, Principal Investigator",[64],{"name":65,"class":6},"Copenhagen Trial Unit, Center for Clinical Intervention Research","100446624","phase-4-the-anaesthetic-ketamine-as-treatment-for-patients-with-severe-acute-brain-injury-100446624",false,"NCT05095857","The Anaesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury","S-ketamine for Cortical Spreading Depolarisation in Patients With Severe Acute Brain Injury","KETA-BID","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Admitted to the NICU with a diagnosis of traumatic brain injury (TBI), aneurysmal subarachnoid haemorrhage (aSAH) or spontaneous intracerebral haemorrhage (ICH).\n* Planned for surgery with a supratentorial craniotomy or craniectomy.\n* Expected to continue sedation and mechanical ventilation after surgery.\n\nExclusion Criteria:\n\n* Neither patient or next of kin understand Danish or English.\n* Known allergy to S-ketamine (the active pharmaceutical ingredient or the excipients).\n* Wake-up call to occur immediately after surgery.\n* Pregnancy (all female participants aged ≤ 50 years will have a urine or blood hCG taken to control for pregnancy).\n* Active anti-psychotic treatment before admission.\n* Current abuse of ketamine.\n* Decision to withdraw active treatment.\n* ICH secondary to a known brain tumour at the time of inclusion.\n\nSince this is an emergency trial informed consent will be obtained from a trial guardian before inclusion of the participant, and informed consent will be sought from next of kin as soon as possible.","ALL","18 Years",{"count":77,"type":78},400,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","Cortical spreading depolarisations are pathological depolarisation waves that occur frequently after severe acute brain injury and has been associated with poor outcome. S-ketamine has been shown to inhibit cortical spreading depolarisations. The aim of the present study is to examine the efficacy and safety of using S-ketamine for treatment of patients with severe acute brain injury, as well as the feasibility of the trial design.",[84,85,86],"Subarachnoid Hemorrhage, Aneurysmal","Intracerebral Hemorrhage","Traumatic Brain Injury",[88,89],"Cortical Spreading Depolarisation","Ketamine","2024-06-24",{"date":92,"type":93},"2024-06-26","ACTUAL",{"date":95,"type":93},"2023-09-15",{"date":97,"type":78},"2028-09-15",{"name":5,"class":6},1]