[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100285135":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":27,"locations":33,"responsibleParty":128,"collaborators":131,"id":135,"slug":18,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":18,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":18,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":36,"whyStopped":18,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"University of Miami","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hypothermia","EXPERIMENTAL","Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.",[13],"Other: Hypothermia",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Standard of care medical treatment, specific to each individual.",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":18},"To deliver intravascular hypothermia, an Alsius Icy CoolGuard® catheter (US Food and Drug Administration approved, Premarket Notification \\[510(k), K030421\\]; Alsius Corporation, Irvine, California) will be inserted through the femoral vein using a sterile technique. Patients will be cooled at a maximum rate (2-2.5 ºC\u002Fhr.) until they reach the target temperature (T 33 ºC), which will be maintained for 48 hours, and then re-warmed at 0.1 ºC\u002Fhr. until normothermia (T 37ºC) is achieved.",[9],[24],{"name":25,"affiliation":5,"role":26},"Allan D Levi, MD, PhD","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"George Jimsheleishvili, MD","CONTACT","305-243-4781","gxj150@miami.edu",[34,52,64,75,85,100,113],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"HonorHealth Research Institute with Barrow Brain and Spine","RECRUITING","Phoenix","Arizona","85027","United States",{"type":42,"coordinates":43},"Point",[44,45],-112.07404,33.44838,{"lat":45,"lon":44},[48],{"name":49,"role":30,"phone":50,"phoneExt":18,"email":51},"Camille Fajardo, CCRC","623-879-1692","cafajardo@honorhealth.com",{"facility":53,"status":36,"city":54,"state":55,"zip":56,"country":40,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Jackson Memorial Hospital","Miami","Florida","33136",{"type":42,"coordinates":58},[59,60],-80.19366,25.77427,{"lat":60,"lon":59},[63],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":18},{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":40,"cosmosGeoPoint":70,"geoPoint":74,"contacts":18},"Emory University School of Medicine","TERMINATED","Atlanta","Georgia","30303-3049",{"type":42,"coordinates":71},[72,73],-84.38798,33.749,{"lat":73,"lon":72},{"facility":76,"status":66,"city":77,"state":78,"zip":79,"country":40,"cosmosGeoPoint":80,"geoPoint":84,"contacts":18},"Indiana University School of Medicine","Indianapolis","Indiana","46202-1000",{"type":42,"coordinates":81},[82,83],-86.15804,39.76838,{"lat":83,"lon":82},{"facility":86,"status":36,"city":87,"state":88,"zip":89,"country":40,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"University of Maryland School of Medicine","Baltimore","Maryland","21201",{"type":42,"coordinates":91},[92,93],-76.61219,39.29038,{"lat":93,"lon":92},[96],{"name":97,"role":30,"phone":98,"phoneExt":18,"email":99},"Leslie Sult, BSN, RN","410-328-3657","lsult@som.umaryland.edu",{"facility":101,"status":36,"city":102,"state":103,"zip":104,"country":40,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107-5125",{"type":42,"coordinates":106},[107,108],-75.16362,39.95238,{"lat":108,"lon":107},[111],{"name":112,"role":30,"phone":18,"phoneExt":18,"email":18},"James Harrop, MD",{"facility":114,"status":36,"city":115,"state":116,"zip":117,"country":40,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Prisma Health - University of South Carolina","Columbia","South Carolina","29203",{"type":42,"coordinates":119},[120,121],-81.03481,34.00071,{"lat":121,"lon":120},[124],{"name":125,"role":30,"phone":126,"phoneExt":18,"email":127},"Paisley Myers, PhD","803-296-9274","paisley.myers@prismahealth.org",{"type":26,"investigatorFullName":129,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Allan D. Levi","Professor and Chairman of Neurological Surgery",[132],{"name":133,"class":134},"United States Department of Defense","FED","100285135",false,"NCT02991690","Systemic Hypothermia in Acute Cervical Spinal Cord Injury","Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study","Inclusion Criteria:\n\n* 18 - 70 years of age\n* AIS Grade A - C\n* Glasgow Coma Scale ≥14\n* Able to start hypothermia treatment within 24 hours of injury\n* Non-penetrating injury. Patients urgently taken to the operating room for surgical reduction may also be included.\n\nExclusion Criteria:\n\n* Age \\> 70 years\n* AIS Grade D\n* Hyperthermia on admission (\\>38.5ºC)\n* Severe systemic injury\n* Severe bleeding\n* Pregnancy\n* Coagulopathy\n* Thrombocytopenia\n* Known prior severe cardiac history\n* Blood dyscrasia\n* Pancreatitis\n* Reynaud's syndrome\n* Cord transection","ALL","18 Years","70 Years",{"count":145,"type":146},120,"ESTIMATED","INTERVENTIONAL",[149],"NA","This study is a prospective multi-center trial designed to determine the safety profile and efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8) Spinal Cord Injury (SCI).",[152],"Spinal Cord Injury, Acute",[9,154,155],"Cervical Spinal Cord Injury","Trauma","2025-11-20",{"date":158,"type":159},"2025-11-21","ACTUAL",{"date":161,"type":159},"2017-08-04",{"date":163,"type":146},"2026-09",{"name":5,"class":6},7]