[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512891":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":44,"centralContacts":48,"locations":53,"responsibleParty":272,"collaborators":276,"id":280,"slug":281,"hasResults":282,"nctId":283,"briefTitle":284,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":282,"sex":287,"minAge":288,"maxAge":289,"enrollmentInfo":290,"targetDuration":35,"studyType":293,"phases":294,"briefSummary":296,"conditions":297,"keywords":300,"overallStatus":56,"whyStopped":35,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Prehospital Intervention Arm","EXPERIMENTAL","1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes, initiated prior to trauma bay arrival and infused to completion following arrival if needed",[13],"Drug: Calcium Gluconate",{"label":15,"type":16,"description":17,"interventionNames":18},"Prehospital Control Arm","PLACEBO_COMPARATOR","Identical volume saline placebo to prehospital intervention arm provided via intravenous or intraosseous access over approximately 2-5 minutes, initiated prior to trauma bay arrival and infused to completion following arrival if needed",[19],"Drug: saline placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Early In-Hospital Intervention Arm","4-unit vasopressin bolus followed by a vasopressin infusion at 0.04 U\u002Fmin for 8 hours. Administration of the bolus will be initiated as soon as feasible and within approximately 2 hours of enrollment. The infusion will be initiated within approximately 30 minutes of the bolus.",[24],"Drug: Vasopressin",{"label":26,"type":16,"description":27,"interventionNames":28},"Early In-Hospital Control Arm","volume matched saline bolus followed by volume matched normal saline placebo infusion for eight hours initiated within approximately two hours of enrollment",[19],[30,36,40],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Calcium Gluconate","1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes",[9],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Vasopressin","4 unit vasopressin bolus followed by vasopressin infusion at 0.04 U\u002Fmin for eight hours",[21],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"saline placebo","saline placebo volume matched to prehospital or in hospital phase",[26,15],[45],{"name":46,"affiliation":5,"role":47},"Jason Sperry, MD","PRINCIPAL_INVESTIGATOR",[49],{"name":46,"role":50,"phone":51,"phoneExt":35,"email":52},"CONTACT","4128028270","sperryjl@upmc.edu",[54,73,88,103,118,133,148,163,178,193,208,219,234,242,257],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"University of Arizona","RECRUITING","Tucson","Arizona","85724","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-110.92648,32.22174,{"lat":66,"lon":65},[69],{"name":70,"role":50,"phone":71,"phoneExt":35,"email":72},"Bellal Joseph, MD","520-626-5056","bjoseph@arizona.edu",{"facility":74,"status":56,"city":75,"state":76,"zip":77,"country":60,"countryCode":61,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"University of Arkansas for Medical Sciences","Little Rock","Arkansas","72205",{"type":63,"coordinates":79},[80,81],-92.28959,34.74648,{"lat":81,"lon":80},[84],{"name":85,"role":50,"phone":86,"phoneExt":35,"email":87},"Joseph Margolick, MD","214-620-3504","Jmargolick@uams.edu",{"facility":89,"status":56,"city":90,"state":91,"zip":92,"country":60,"countryCode":61,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Zuckerberg San Francisco General Hospital and Trauma Center at University of California, San Francisco","San Francisco","California","94110",{"type":63,"coordinates":94},[95,96],-122.41942,37.77493,{"lat":96,"lon":95},[99],{"name":100,"role":50,"phone":101,"phoneExt":35,"email":102},"Lucy Kornblith, MD","415-609-6924","Lucy.Kornblith@ucsf.edu",{"facility":104,"status":56,"city":105,"state":106,"zip":107,"country":60,"countryCode":61,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Denver Health Medical Center","Denver","Colorado","80204",{"type":63,"coordinates":109},[110,111],-104.9847,39.73915,{"lat":111,"lon":110},[114],{"name":115,"role":50,"phone":116,"phoneExt":35,"email":117},"Ernest Moore, MD","303-602-1820","ernest.moore@dhha.org",{"facility":119,"status":56,"city":120,"state":121,"zip":122,"country":60,"countryCode":61,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"University of Miami","Miami","Florida","33136",{"type":63,"coordinates":124},[125,126],-80.19366,25.77427,{"lat":126,"lon":125},[129],{"name":130,"role":50,"phone":131,"phoneExt":35,"email":132},"Jonathan Meizoso, MD","305-585-1178","jpmeizoso@med.miami.edu",{"facility":134,"status":56,"city":135,"state":136,"zip":137,"country":60,"countryCode":61,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"University of Maryland, Baltimore","Baltimore","Maryland","21201",{"type":63,"coordinates":139},[140,141],-76.61219,39.29038,{"lat":141,"lon":140},[144],{"name":145,"role":50,"phone":146,"phoneExt":35,"email":147},"William Teeter, MD, MS","410-328-9878","William.teeter@som.umaryland.edu",{"facility":149,"status":56,"city":150,"state":151,"zip":152,"country":60,"countryCode":61,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Hennepin County Medical Center","Minneapolis","Minnesota","55415",{"type":63,"coordinates":154},[155,156],-93.26384,44.97997,{"lat":156,"lon":155},[159],{"name":160,"role":50,"phone":161,"phoneExt":35,"email":162},"Michael Puskarich, MD, MS","612-873-7448","mike.puskarich@hcmed.org",{"facility":164,"status":56,"city":165,"state":166,"zip":167,"country":60,"countryCode":61,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"University of Missouri Health Care","Columbia","Missouri","65202",{"type":63,"coordinates":169},[170,171],-92.33407,38.95171,{"lat":171,"lon":170},[174],{"name":175,"role":50,"phone":176,"phoneExt":35,"email":177},"Jeffrey Coughenour, MD","573-882-1379","coughenourj@health.missouri.edu",{"facility":179,"status":56,"city":180,"state":181,"zip":182,"country":60,"countryCode":61,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"University of New Mexico","Albuquerque","New Mexico","87131",{"type":63,"coordinates":184},[185,186],-106.65114,35.08449,{"lat":186,"lon":185},[189],{"name":190,"role":50,"phone":191,"phoneExt":35,"email":192},"Ming Li Wang, MD","505-272-0434","MLWang@salud.unm.edu",{"facility":194,"status":56,"city":195,"state":196,"zip":197,"country":60,"countryCode":61,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"The Ohio State University Wexner Medical Center","Columbus","Ohio","43210",{"type":63,"coordinates":199},[200,201],-82.99879,39.96118,{"lat":201,"lon":200},[204],{"name":205,"role":50,"phone":206,"phoneExt":35,"email":207},"John Loftus, MD","614-685-2307","John.Loftus@osumc.edu",{"facility":209,"status":56,"city":195,"state":196,"zip":210,"country":60,"countryCode":61,"cosmosGeoPoint":211,"geoPoint":213,"contacts":214},"Mount Carmel East Hospital","43213",{"type":63,"coordinates":212},[200,201],{"lat":201,"lon":200},[215],{"name":216,"role":50,"phone":217,"phoneExt":35,"email":218},"M. Chance Spalding, DO, PhD, FACS","614.638.6143","mcspalding62@gmail.com",{"facility":220,"status":56,"city":221,"state":222,"zip":223,"country":60,"countryCode":61,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Allegheny Health Network","Pittsburgh","Pennsylvania","15212",{"type":63,"coordinates":225},[226,227],-79.99589,40.44062,{"lat":227,"lon":226},[230],{"name":231,"role":50,"phone":232,"phoneExt":35,"email":233},"Philip Nawrocki, MD","412-487-6590","philip.nawrocki@ahn.org",{"facility":5,"status":56,"city":221,"state":222,"zip":235,"country":60,"countryCode":61,"cosmosGeoPoint":236,"geoPoint":238,"contacts":239},"15213",{"type":63,"coordinates":237},[226,227],{"lat":227,"lon":226},[240],{"name":46,"role":50,"phone":241,"phoneExt":35,"email":52},"4126473065",{"facility":243,"status":56,"city":244,"state":245,"zip":246,"country":60,"countryCode":61,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Texas Tech University Health Sciences Center","Lubbock","Texas","79430",{"type":63,"coordinates":248},[249,250],-101.85517,33.57786,{"lat":250,"lon":249},[253],{"name":254,"role":50,"phone":255,"phoneExt":35,"email":256},"Jayne McCauley, MD","806-743-2373","Jayne.mccauley@ttuhsc.edu",{"facility":258,"status":56,"city":259,"state":260,"zip":261,"country":60,"countryCode":61,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"University of Washington Harborview Medical Center","Seattle","Washington","98104",{"type":63,"coordinates":263},[264,265],-122.33207,47.60621,{"lat":265,"lon":264},[268],{"name":269,"role":50,"phone":270,"phoneExt":35,"email":271},"Andrew Latimer, MD, FAEMS","206-744-5676","alatim@uw.edu",{"type":273,"investigatorFullName":274,"investigatorTitle":275,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"SPONSOR_INVESTIGATOR","Jason Sperry","Professor",[277],{"name":278,"class":279},"United States Department of Defense","FED","100512891","phase-2-calcium-and-vasopressin-following-injury-early-resuscitation-cavalier-trial-100512891",false,"NCT05958342","CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial","CAVALIER","Inclusion Criteria:\n\nPrehospital Phase:\n\nInjured patients at risk of hemorrhagic shock being transported from scene or referral hospital to a participating CAVALIER trial site who meet the following criteria:\n\n1A. Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital, or during anticipated transport to a participating CAVALIER trial site\n\nOR\n\n1B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, or during anticipated transport to a participating CAVALIER trial site\n\nEarly In-Hospital Phase:\n\nInjured patients at a participating CAVALIER trial site at risk of hemorrhagic shock who meet the following criteria:\n\n1A. Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital, during transport, or in emergency department of a participating CAVALIER trial site\n\nOR\n\n1B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, during transport, or in emergency department of a participating CAVALIER trial site\n\nAND\n\n2.Blood\u002Fblood component transfusion initiated in prehospital setting or deemed clinically indicated within 60 minutes of arrival at the enrolling trauma center\n\nAND 3. Clinical team deems Operating Room for major hemorrhage control procedure (e.g., laparotomy, thoracotomy, vascular exploration or extremity amputation) indicated within 60 minutes of arrival at the enrolling trauma center\n\nAND\n\n4\\. Anticipated admission to intensive care unit (ICU)\n\nExclusion Criteria:\n\nPrehospital Phase\n\n1. Wearing NO CAVALIER opt-out bracelet\n2. Age \\> 90 or \\\u003C 18 years of age\n3. Isolated fall from standing injury mechanism\n4. Known prisoner\n5. Known pregnancy\n6. Traumatic arrest with \\> 5 minutes of CPR without return of vital signs\n7. Brain matter exposed or penetrating brain injury\n8. Isolated drowning or hanging victims\n9. Objection to study voiced by subject or family member at the scene or at the trauma center\n10. Inability to obtain IV\u002FIO access\n\nEarly In-Hospital Phase:\n\n1. Wearing NO CAVALIER opt-out bracelet\n2. Age \\> 90 or \\\u003C 18 years of age\n3. Isolated fall from standing injury mechanism\n4. Known prisoner\n5. Known pregnancy\n6. Traumatic arrest with \\> 5 minutes of CPR without return of vital signs\n7. Brain matter exposed or penetrating brain injury\n8. Isolated drowning or hanging victims\n9. Objection to study voiced by subject or family member at the scene or at the trauma center\n10. Inability to obtain IV access","ALL","18 Years","90 Years",{"count":291,"type":292},1050,"ESTIMATED","INTERVENTIONAL",[295],"PHASE2","The CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) Trial is a proposed 4 year, double-blind, mutli-center, prehospital and early in hospital phase randomized trial designed to determine the efficacy and safety of prehospital calcium and early in hospital vasopressin in patients at risk of hemorrhagic shock.",[298,299],"Trauma","Hemorrhage",[301,302,303,304],"hemorrhagic shock","trauma","calcium gluconate","vasopressin","2026-06-01",{"date":307,"type":308},"2026-06-03","ACTUAL",{"date":310,"type":308},"2024-06-30",{"date":312,"type":292},"2028-03",{"name":274,"class":6},15]