[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609715":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":23,"locations":29,"responsibleParty":96,"collaborators":98,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":10,"enrollmentInfo":112,"targetDuration":10,"studyType":115,"phases":10,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":127,"whyStopped":10,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Cerus Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IFC arm",null,"Subjects will receive Pathogen Reduced Cryoprecipitated Fibrinogen Complex (IFC) for fibrinogen supplementation.",[13],"Biological: Pathogen Reduced Cryoprecipitated Fibrinogen Complex",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Pathogen Reduced Cryoprecipitated Fibrinogen Complex","Pre-thawed IFC will be administered per standard of care when cryoprecipitate administration is clinically indicated by the treating physician and IFC is available. Participants must have functional hypofibrinogenemia by Quantra® POC testing with FCS \\\u003C1.6 hPA. Additional IFC may be administered based on repeat POC testing or clinical judgment.",[9],[21,22],"INTERCEPT Fibrinogen Complex","IFC",[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Laurence Corash, MD","CONTACT","925-288-6118","lcorash@cerus.com",[30,48,63,81],{"facility":31,"status":10,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Anschutz Medical Center, University of Colorado","Aurora","Colorado","80045","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-104.83192,39.72943,{"lat":41,"lon":40},[44],{"name":45,"role":26,"phone":46,"phoneExt":10,"email":47},"Mitchell Cohen, MD","303-602-1861","mitchell.cohen@cuanschutz.edu",{"facility":49,"status":10,"city":50,"state":51,"zip":52,"country":35,"countryCode":36,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Ryder Trauma Center\u002FJackson Memorial Hospital, University of Miami","Miami","Florida","33136",{"type":38,"coordinates":54},[55,56],-80.19366,25.77427,{"lat":56,"lon":55},[59],{"name":60,"role":26,"phone":61,"phoneExt":10,"email":62},"Jonathan Meizoso, MD, MSPH","303-585-1178","jpmeizoso@miami.edu",{"facility":64,"status":10,"city":65,"state":66,"zip":67,"country":35,"countryCode":36,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"R Adams Cowley Shock Trauma Center, University of Maryland","Baltimore","Maryland","21201",{"type":38,"coordinates":69},[70,71],-76.61219,39.29038,{"lat":71,"lon":70},[74,78],{"name":75,"role":26,"phone":76,"phoneExt":10,"email":77},"Deborah M Stein, MD, MPH","410-328-3495","dstein@som.umaryland.edu",{"name":79,"role":26,"phone":76,"phoneExt":10,"email":80},"Rosemary Kozar, MD, PhD","rkozar@som.umaryland.edu",{"facility":82,"status":10,"city":83,"state":84,"zip":85,"country":35,"countryCode":36,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Barnes Jewish Hospital, Washington University of Saint Louis","St Louis","Missouri","63110",{"type":38,"coordinates":87},[88,89],-90.19789,38.62727,{"lat":89,"lon":88},[92],{"name":93,"role":26,"phone":94,"phoneExt":10,"email":95},"Grant Bochicchio, MD, MPH","314-747-2829","gbochicchio@wustl.edu",{"type":97,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[99],{"name":100,"class":101},"Coalition for National Trauma Research","OTHER","100609715","cryo-first-effectiveness-of-intercept-fibrinogen-complex-ifc-for-trauma-associated-hemorrhage-100609715",false,"NCT07218185","Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage","Cryo-FIRST: Cryoprecipitate For Immediate Resuscitation in Severe Trauma: Effectiveness of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) for Treatment of Trauma Associated Hemorrhage","CRYO-FIRST","Inclusion Criteria:\n\n* Traumatic injury\n* Age ≥18 years or estimated weight ≥50 kg, if age unknown\n* Presenting to a participating trauma center ≤1 hour from estimated time of injury\n* Functional hypofibrinogenemia upon arrival to the trauma center as measured by point-of-care testing (Quantra®) with FCS \\\u003C1.6 hPa\n* Hemorrhagic shock, defined as:\n\n  1. Initiation of transfusion of any uncrossmatched blood product;\n  2. Evidence of active hemorrhage as judged by the attending trauma surgeon; and\n  3. Initiation of the participating trauma center's massive transfusion protocol (MTP)\n* IFC administration is clinically indicated per the treating physician\n* IFC is available at the time of enrollment\n\nExclusion Criteria:\n\n* Suspected isolated severe brain or spinal cord injury\n* Isolated drowning or hanging\n* Burns \\>20% total body surface area (TBSA)\n* Known pregnancy\n* Admitted from a correctional facility\n* Known do not resuscitate (DNR) order\n* Traumatic arrest \\>5 minutes, defined as continuous CPR \\>5 minutes at any time point prior to enrollment in the study\n* Isolated fall from standing\n* Emergency Department (ED) thoracotomy","ALL","18 Years",{"count":113,"type":114},320,"ESTIMATED","OBSERVATIONAL","The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) in trauma patients with hemorrhagic shock (HS) and functional hypofibrinogenemia. This study will determine whether rapid point-of-care testing for functional hypofibrinogenemia and availability of a shelf-stable fibrinogen complex (IFC) results in shorter time to administration of fibrinogen replacement and correction of functional hypofibrinogenemia, as compared with historical controls and published literature using conventional cryoprecipitate-AHF (CRYO-AHF).\n\nThis study aims to:\n\n* Demonstrate the feasibility and response to early administration of pre-thawed IFC when ordered during initial resuscitation of severely injured patients with HS and functional hypofibrinogenemia.\n* Assess the effectiveness of early administration of pre-thawed IFC on correction of functional hypofibrinogenemia and on proximate process measures of resuscitation, including time to hemostasis, time to completion of resuscitation, and total volume of resuscitation.\n* Assess clinical outcomes in severely injured patients with HS and functional hypofibrinogenemia receiving early administration of pre-thawed IFC.",[118,119,120,121],"Hypofibrinogenemia","Hemorrhage","Trauma Associated Hemorrhage","Hemorrhagic Shock",[123,119,124,125,21,17,121,126],"Fibrinogen","Trauma","Resuscitation","Quantra","NOT_YET_RECRUITING","2026-06-16",{"date":130,"type":131},"2026-06-17","ACTUAL",{"date":133,"type":114},"2026-07",{"date":135,"type":114},"2028-08",{"name":5,"class":6},4]