[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"trauma-associated-hemorrhage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:trauma-associated-hemorrhage":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":19,"type":20},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.",[24,25,26,27],"Hypofibrinogenemia","Hemorrhage","Trauma Associated Hemorrhage","Hemorrhagic Shock",[29,25,30,31,32,33,27,34],"Fibrinogen","Trauma","Resuscitation","INTERCEPT Fibrinogen Complex","Pathogen Reduced Cryoprecipitated Fibrinogen Complex","Quantra","NOT_YET_RECRUITING","2026-06-16",{"date":38,"type":39},"2026-06-17","ACTUAL",{"date":41,"type":20},"2026-07",{"date":43,"type":20},"2028-08",{"name":45,"class":46},"Cerus Corporation","INDUSTRY",4,""]