[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557642":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":27,"locations":18,"responsibleParty":33,"collaborators":36,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":18,"enrollmentInfo":49,"targetDuration":18,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":64,"whyStopped":18,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":18},{"fullName":5,"class":6},"London Health Sciences Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Therapeutic Normothermia Group","ACTIVE_COMPARATOR","Participants randomized to this group will be placed under a targeted temperature model aiming for normothermia for 72 hours. Temperature and interventions will be monitored every 4 hours for the entirety of the 24 hours. Participants will be followed post-discharge and will undergo cognitive assessments at 3 and 6 months.",[13],"Other: Therapeutic Normothermia Group",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Participants randomized to this group will undergo usual care in the Critical Care Trauma Centre. Temperature will be monitored as per standard of care. Participants will be followed post-discharge and will undergo cognitive assessments at 3 and 6 months.",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":18},"Maintenance of a body temperature between 35 and 37 degrees Celsius using conservative and pharmacological interventions for 72 hours.",[9],[24],{"name":25,"affiliation":5,"role":26},"Ian Ball, MD","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Hana Geres, MB BCh BAO","CONTACT","6477747081","hgeres@uwo.ca",{"type":26,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Ian Ball","Dr.",[37],{"name":38,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","100557642","therapeutic-normothermia-in-tbi-100557642",false,"NCT06540768","Therapeutic Normothermia in TBI","Therapeutic Normothermia in the Treatment of Traumatic Brain Injury Trial: Feasibility Trial","MAMBA-FT","Inclusion Criteria:\n\n* Adult patients (\\>= 18 years of age) who present through the LHSC trauma service and have sustained a TBI.\n* A Glasgow Coma Scale (GCS) of 5-12, inclusive, prior to intubation.\n\nExclusion Criteria:\n\n* GCS at time of presentation of 4 or less or 13 or more.\n* Patients not expected to survive 48 hours.\n* \\>24 hours from injury at time of enrollment.","ALL","18 Years",{"count":50,"type":51},50,"ESTIMATED","INTERVENTIONAL",[54],"NA","This feasibility trial is the first step in testing the hypothesis that maintenance of normal body temperature, called therapeutic normothermia (TN), for 72 continuous hours in traumatic brain injury (TBI) patients can improve cognitive function. The trial aims to answer the following questions:\n\n1. Is it feasible to conduct this study? Conducting the trial includes the ability to identify and enroll appropriate participants, implement TN, and collect the required data.\n2. Can the Creyos Health platform cognitive assessment tool be used to assess and quantify cognitive outcomes in TBI patients?\n\nResearchers will address the aforementioned questions by looking at the following factors:\n\n1. Identification and enrollment rates of appropriate patients\n2. Implementation of the intervention and appropriate data collection while admitted\n3. Accurate follow up and continued data collection post-discharge\n4. Accessibility and ease of use of the Creyos Health platform cognitive assessment tool\n\nParticipants will undergo the following procedure:\n\n1. Admission to the Critical Care Trauma Centre through the trauma service\n2. Allocation to the intervention or no intervention group\n3. Implementation of the intervention or of usual care for a continuous 72 hours\n4. Completion of the Creyos Health platform cognitive assessment tool at 3 and 6 months post-discharge from the Critical Care Trauma Centre",[57],"Traumatic Brain Injury",[59,60,61,62,63],"TBI","therapeutic normothermia","targeted temperature management","cognitive outcomes","traumatic brain injury","NOT_YET_RECRUITING","2024-12-11",{"date":67,"type":68},"2024-12-16","ACTUAL",{"date":70,"type":51},"2025-01",{"date":72,"type":51},"2025-12",{"name":5,"class":6}]