[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609715":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":23,"locations":29,"responsibleParty":95,"collaborators":97,"id":101,"slug":10,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":10,"enrollmentInfo":110,"targetDuration":10,"studyType":113,"phases":10,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":125,"whyStopped":10,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"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",[30,47,62,80],{"facility":31,"status":10,"city":32,"state":33,"zip":34,"country":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Anschutz Medical Center, University of Colorado","Aurora","Colorado","80045","United States",{"type":37,"coordinates":38},"Point",[39,40],-104.83192,39.72943,{"lat":40,"lon":39},[43],{"name":44,"role":26,"phone":45,"phoneExt":10,"email":46},"Mitchell Cohen, MD","303-602-1861","mitchell.cohen@cuanschutz.edu",{"facility":48,"status":10,"city":49,"state":50,"zip":51,"country":35,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Ryder Trauma Center\u002FJackson Memorial Hospital, University of Miami","Miami","Florida","33136",{"type":37,"coordinates":53},[54,55],-80.19366,25.77427,{"lat":55,"lon":54},[58],{"name":59,"role":26,"phone":60,"phoneExt":10,"email":61},"Jonathan Meizoso, MD, MSPH","303-585-1178","jpmeizoso@miami.edu",{"facility":63,"status":10,"city":64,"state":65,"zip":66,"country":35,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"R Adams Cowley Shock Trauma Center, University of Maryland","Baltimore","Maryland","21201",{"type":37,"coordinates":68},[69,70],-76.61219,39.29038,{"lat":70,"lon":69},[73,77],{"name":74,"role":26,"phone":75,"phoneExt":10,"email":76},"Deborah M Stein, MD, MPH","410-328-3495","dstein@som.umaryland.edu",{"name":78,"role":26,"phone":75,"phoneExt":10,"email":79},"Rosemary Kozar, MD, PhD","rkozar@som.umaryland.edu",{"facility":81,"status":10,"city":82,"state":83,"zip":84,"country":35,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Barnes Jewish Hospital, Washington University of Saint Louis","St Louis","Missouri","63110",{"type":37,"coordinates":86},[87,88],-90.19789,38.62727,{"lat":88,"lon":87},[91],{"name":92,"role":26,"phone":93,"phoneExt":10,"email":94},"Grant Bochicchio, MD, MPH","314-747-2829","gbochicchio@wustl.edu",{"type":96,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[98],{"name":99,"class":100},"Coalition for National Trauma Research","OTHER","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":111,"type":112},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.",[116,117,118,119],"Hypofibrinogenemia","Hemorrhage","Trauma Associated Hemorrhage","Hemorrhagic Shock",[121,117,122,123,21,17,119,124],"Fibrinogen","Trauma","Resuscitation","Quantra","NOT_YET_RECRUITING","2026-06-16",{"date":128,"type":129},"2026-06-17","ACTUAL",{"date":131,"type":112},"2026-07",{"date":133,"type":112},"2028-08",{"name":5,"class":6},4]