[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100240350":3},{"organization":4,"armGroups":7,"interventions":50,"overallOfficials":88,"centralContacts":101,"locations":108,"responsibleParty":274,"collaborators":278,"id":285,"slug":286,"hasResults":287,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":287,"sex":293,"minAge":294,"maxAge":295,"enrollmentInfo":296,"targetDuration":106,"studyType":299,"phases":300,"briefSummary":302,"conditions":303,"keywords":106,"overallStatus":111,"whyStopped":106,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},{"fullName":5,"class":6},"Hennepin Healthcare Research Institute","OTHER",[8,14,19,24,29,34,39,44],{"label":9,"type":10,"description":11,"interventionNames":12},"Hyperbaric oxygen (1.5 ATA, no NBH)","EXPERIMENTAL","Hyperbaric oxygen at 1.5 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.",[13],"Drug: Hyperbaric oxygen (1.5 ATA, no NBH)",{"label":15,"type":10,"description":16,"interventionNames":17},"Hyperbaric oxygen (2.0 ATA, no NBH)","Hyperbaric oxygen at 2.0 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.",[18],"Drug: Hyperbaric oxygen (2.0 ATA, no NBH)",{"label":20,"type":10,"description":21,"interventionNames":22},"Hyperbaric oxygen (2.5 ATA, no NBH)","Hyperbaric oxygen at 2.5 ATA for 1 hour, without NBH. This treatment is administered twice a day for 5 days.",[23],"Drug: Hyperbaric oxygen (2.5 ATA, no NBH)",{"label":25,"type":10,"description":26,"interventionNames":27},"Hyperbaric oxygen (1.5 ATA + NBH)","Hyperbaric oxygen at 1.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.",[28],"Drug: Hyperbaric oxygen (1.5 ATA + NBH)",{"label":30,"type":10,"description":31,"interventionNames":32},"Hyperbaric oxygen (2.0 ATA + NBH)","Hyperbaric oxygen at 2.0 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.",[33],"Drug: Hyperbaric oxygen (2.0 ATA + NBH)",{"label":35,"type":10,"description":36,"interventionNames":37},"Hyperbaric oxygen (2.5 ATA + NBH)","Hyperbaric oxygen at 2.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.",[38],"Drug: Hyperbaric oxygen (2.5 ATA + NBH)",{"label":40,"type":10,"description":41,"interventionNames":42},"Normobaric Hyperoxia (NBH)","Normobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.",[43],"Drug: Normobaric Hyperoxia (NBH)",{"label":45,"type":46,"description":47,"interventionNames":48},"Usual care","ACTIVE_COMPARATOR","Usual care for severe TBI",[49],"Other: Usual Care",[51,57,61,65,69,73,77,82],{"type":52,"name":9,"description":53,"armGroupLabels":54,"otherNames":55},"DRUG","HBO at 1.5 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead",[9],[56],"HBO",{"type":52,"name":15,"description":58,"armGroupLabels":59,"otherNames":60},"HBO at 2.0 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead",[15],[56],{"type":52,"name":20,"description":62,"armGroupLabels":63,"otherNames":64},"HBO at 2.5 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead",[20],[56],{"type":52,"name":25,"description":66,"armGroupLabels":67,"otherNames":68},"HBO at 1.5 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead",[25],[56],{"type":52,"name":30,"description":70,"armGroupLabels":71,"otherNames":72},"HBO at 2.0 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead",[30],[56],{"type":52,"name":35,"description":74,"armGroupLabels":75,"otherNames":76},"HBO at 2.5 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead",[35],[56],{"type":52,"name":40,"description":78,"armGroupLabels":79,"otherNames":80},"100% fraction of inspired oxygen (FiO2) for 4.5 hours twice a day for five days or until patient following commands or brain dead",[40],[81],"NBH",{"type":6,"name":83,"description":84,"armGroupLabels":85,"otherNames":86},"Usual Care","Will be treated with usual and customary care for severe traumatic brain injury",[45],[87],"Standard of Care",[89,93,96,99],{"name":90,"affiliation":91,"role":92},"Gaylan L Rockswold, M.D., Ph.D.","Hennepin County Medical Center, Minneapolis","PRINCIPAL_INVESTIGATOR",{"name":94,"affiliation":95,"role":92},"William Barsan, MD","University of Michigan",{"name":97,"affiliation":98,"role":92},"Byron Gajewski, Ph.D.","University of Kansas Medical Center",{"name":100,"affiliation":95,"role":92},"Frederick K Korley, M.D., Ph.D.",[102],{"name":103,"role":104,"phone":105,"phoneExt":106,"email":107},"Gaylan L. Rockswold, M.D., Ph.D.","CONTACT","612-873-2810",null,"gaylan.rockswold@hcmed.org",[109,129,145,161,177,193,209,225,236,252,262],{"facility":110,"status":111,"city":112,"state":113,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"UCSD Medical Center - Hillcrest Hospital","RECRUITING","San Diego","California","92103","United States","US",{"type":118,"coordinates":119},"Point",[120,121],-117.16472,32.71571,{"lat":121,"lon":120},[124,127],{"name":125,"role":104,"phone":106,"phoneExt":106,"email":126},"Lilian Von Husen","lvonhuse@health.ucsd.edu",{"name":128,"role":92,"phone":106,"phoneExt":106,"email":106},"Jessica Weaver, MD",{"facility":130,"status":111,"city":131,"state":132,"zip":133,"country":115,"countryCode":116,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"St. Mary's Medical Center","West Palm Beach","Florida","33407",{"type":118,"coordinates":135},[136,137],-80.05337,26.71534,{"lat":137,"lon":136},[140,143],{"name":141,"role":104,"phone":106,"phoneExt":106,"email":142},"Tracy RODRIGUEZ","Tracy.Rodriguez@tenethealth.com",{"name":144,"role":92,"phone":106,"phoneExt":106,"email":106},"Faris Azar, MD",{"facility":146,"status":111,"city":147,"state":148,"zip":149,"country":115,"countryCode":116,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"University of Iowa Hospitals and Clinics","Iowa City","Iowa","52242",{"type":118,"coordinates":151},[152,153],-91.53017,41.66113,{"lat":153,"lon":152},[156,159],{"name":157,"role":104,"phone":106,"phoneExt":106,"email":158},"Catherine Fairfield","catherine-fairfield@uiowa.edu",{"name":160,"role":92,"phone":106,"phoneExt":106,"email":106},"Nicholas Mohr, MD",{"facility":162,"status":111,"city":163,"state":164,"zip":165,"country":115,"countryCode":116,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"University of Kentucky Hospital","Lexington","Kentucky","40536",{"type":118,"coordinates":167},[168,169],-84.47772,37.98869,{"lat":169,"lon":168},[172,175],{"name":173,"role":104,"phone":106,"phoneExt":106,"email":174},"Ronda A PETREY","ronda.petrey@uky.edu",{"name":176,"role":92,"phone":106,"phoneExt":106,"email":106},"David Dornbos, MD",{"facility":178,"status":111,"city":179,"state":180,"zip":181,"country":115,"countryCode":116,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"University of Maryland","Baltimore","Maryland","21201",{"type":118,"coordinates":183},[184,185],-76.61219,39.29038,{"lat":185,"lon":184},[188,191],{"name":189,"role":104,"phone":106,"phoneExt":106,"email":190},"Leslie Sult","lsult@som.umaryland.edu",{"name":192,"role":92,"phone":106,"phoneExt":106,"email":106},"Kinjal Sethuraman, MD",{"facility":194,"status":111,"city":195,"state":196,"zip":197,"country":115,"countryCode":116,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Detroit Receiving Hospital","Detroit","Michigan","48201",{"type":118,"coordinates":199},[200,201],-83.04575,42.33143,{"lat":201,"lon":200},[204,207],{"name":205,"role":104,"phone":106,"phoneExt":106,"email":206},"Nick Wesner","nicholas.wesner@wayne.edu",{"name":208,"role":92,"phone":106,"phoneExt":106,"email":106},"Anthony Lagina, MD",{"facility":210,"status":111,"city":211,"state":212,"zip":213,"country":115,"countryCode":116,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Hennepin County Hospital","Minneapolis","Minnesota","55415",{"type":118,"coordinates":215},[216,217],-93.26384,44.97997,{"lat":217,"lon":216},[220,223],{"name":221,"role":104,"phone":106,"phoneExt":106,"email":222},"Jessica Gieseke","giese141@umn.edu",{"name":224,"role":92,"phone":106,"phoneExt":106,"email":106},"Sam Cramer, MD, PhD",{"facility":226,"status":227,"city":228,"state":229,"zip":230,"country":115,"countryCode":116,"cosmosGeoPoint":231,"geoPoint":235,"contacts":106},"University of Nebraska Medical Center","COMPLETED","Omaha","Nebraska","68198",{"type":118,"coordinates":232},[233,234],-95.94043,41.25626,{"lat":234,"lon":233},{"facility":237,"status":111,"city":238,"state":239,"zip":240,"country":115,"countryCode":116,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Duke University Hospital","Durham","North Carolina","27710",{"type":118,"coordinates":242},[243,244],-78.89862,35.99403,{"lat":244,"lon":243},[247,250],{"name":248,"role":104,"phone":106,"phoneExt":106,"email":249},"Tammy Hawley","tammy.hawley@duke.edu",{"name":251,"role":92,"phone":106,"phoneExt":106,"email":106},"Katherine Colton, MD",{"facility":253,"status":227,"city":254,"state":255,"zip":256,"country":115,"countryCode":116,"cosmosGeoPoint":257,"geoPoint":261,"contacts":106},"The Ohio State University Wexner Medical Center","Columbus","Ohio","43210",{"type":118,"coordinates":258},[259,260],-82.99879,39.96118,{"lat":260,"lon":259},{"facility":263,"status":227,"city":264,"state":265,"zip":266,"country":267,"countryCode":268,"cosmosGeoPoint":269,"geoPoint":273,"contacts":106},"Hamilton Heath Services","Hamilton","Ontario","L8L 2X2","Canada","CA",{"type":118,"coordinates":270},[271,272],-79.84963,43.25011,{"lat":272,"lon":271},{"type":275,"investigatorFullName":276,"investigatorTitle":277,"investigatorAffiliation":5,"oldNameTitle":106,"oldOrganization":106},"SPONSOR_INVESTIGATOR","Gaylan Rockswold","M.D., Neurosurgery",[279,282],{"name":280,"class":281},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",{"name":283,"class":284},"Strategies to Innovate EmeRgENcy Care Clinical Trials Network","NETWORK","100240350","phase-2-hyperbaric-oxygen-brain-injury-treatment-trial-100240350",false,"NCT02407028","Hyperbaric Oxygen Brain Injury Treatment Trial","Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial","HOBIT","Inclusion Criteria:\n\n* Age 16 years or older and 65 years or younger\n* Present with severe TBI, defined as Glasgow Coma Scale (GCS) of 3 to 8.\n* Marshall computerized tomography (CT) score \\>1 in patients with a GCS of 7 or 8 or patients with an alcohol level \\>200 mg\u002Fdl\n* Ability to initiate the first hyperbaric oxygen treatment within 8 hours of admission in patients not requiring a craniotomy\u002Fcraniectomy or any other major surgical procedure OR\n* Ability to initiate the first hyperbaric oxygen treatment within 14 hours of admission in patients requiring a craniotomy\u002Fcraniectomy or major surgical procedure\n\nExclusion Criteria:\n\n* First hyperbaric oxygen treatment cannot be initiated within 24 hours of injury\n* GCS of 3 with mid-position and non-reactive pupils bilaterally (4mm)\n* Penetrating head injury\n* Pregnant\n* Pre-existing neurologic disease (e.g. TBI or stroke or neurodegenerative disorder) with confounding residual neurologic deficits\n* Unstable acute spinal cord injury\n* Fixed coagulopathy\n* Severe hypoxia\n* Cardiopulmonary resuscitation performed\n* Coma suspected to de due to primarily non-TBI causes\n* Any contraindications to the study intervention","ALL","16 Years","65 Years",{"count":297,"type":298},200,"ESTIMATED","INTERVENTIONAL",[301],"PHASE2","The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial.",[304],"Traumatic Brain Injury","2026-05-29",{"date":307,"type":308},"2026-06-02","ACTUAL",{"date":310,"type":308},"2018-06-25",{"date":312,"type":298},"2029-06-30",{"name":276,"class":6},11]