[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100285135":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":27,"locations":33,"responsibleParty":129,"collaborators":132,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":18,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":18,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":36,"whyStopped":18,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"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",[34,53,65,76,86,101,114],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"HonorHealth Research Institute with Barrow Brain and Spine","RECRUITING","Phoenix","Arizona","85027","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-112.07404,33.44838,{"lat":46,"lon":45},[49],{"name":50,"role":30,"phone":51,"phoneExt":18,"email":52},"Camille Fajardo, CCRC","623-879-1692","cafajardo@honorhealth.com",{"facility":54,"status":36,"city":55,"state":56,"zip":57,"country":40,"countryCode":41,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Jackson Memorial Hospital","Miami","Florida","33136",{"type":43,"coordinates":59},[60,61],-80.19366,25.77427,{"lat":61,"lon":60},[64],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":18},{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":40,"countryCode":41,"cosmosGeoPoint":71,"geoPoint":75,"contacts":18},"Emory University School of Medicine","TERMINATED","Atlanta","Georgia","30303-3049",{"type":43,"coordinates":72},[73,74],-84.38798,33.749,{"lat":74,"lon":73},{"facility":77,"status":67,"city":78,"state":79,"zip":80,"country":40,"countryCode":41,"cosmosGeoPoint":81,"geoPoint":85,"contacts":18},"Indiana University School of Medicine","Indianapolis","Indiana","46202-1000",{"type":43,"coordinates":82},[83,84],-86.15804,39.76838,{"lat":84,"lon":83},{"facility":87,"status":36,"city":88,"state":89,"zip":90,"country":40,"countryCode":41,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"University of Maryland School of Medicine","Baltimore","Maryland","21201",{"type":43,"coordinates":92},[93,94],-76.61219,39.29038,{"lat":94,"lon":93},[97],{"name":98,"role":30,"phone":99,"phoneExt":18,"email":100},"Leslie Sult, BSN, RN","410-328-3657","lsult@som.umaryland.edu",{"facility":102,"status":36,"city":103,"state":104,"zip":105,"country":40,"countryCode":41,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107-5125",{"type":43,"coordinates":107},[108,109],-75.16362,39.95238,{"lat":109,"lon":108},[112],{"name":113,"role":30,"phone":18,"phoneExt":18,"email":18},"James Harrop, MD",{"facility":115,"status":36,"city":116,"state":117,"zip":118,"country":40,"countryCode":41,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Prisma Health - University of South Carolina","Columbia","South Carolina","29203",{"type":43,"coordinates":120},[121,122],-81.03481,34.00071,{"lat":122,"lon":121},[125],{"name":126,"role":30,"phone":127,"phoneExt":18,"email":128},"Paisley Myers, PhD","803-296-9274","paisley.myers@prismahealth.org",{"type":26,"investigatorFullName":130,"investigatorTitle":131,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Allan D. Levi","Professor and Chairman of Neurological Surgery",[133],{"name":134,"class":135},"United States Department of Defense","FED","100285135","systemic-hypothermia-in-acute-cervical-spinal-cord-injury-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":147,"type":148},120,"ESTIMATED","INTERVENTIONAL",[151],"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).",[154],"Spinal Cord Injury, Acute",[9,156,157],"Cervical Spinal Cord Injury","Trauma","2025-11-20",{"date":160,"type":161},"2025-11-21","ACTUAL",{"date":163,"type":161},"2017-08-04",{"date":165,"type":148},"2026-09",{"name":5,"class":6},7]