[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613381":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":54,"collaborators":24,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":24,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":24,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":76,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Trauma Hemostatis and Oxygenation Research (THOR) Network","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Antihemophilic Factor (AHF)","ACTIVE_COMPARATOR","AHF is the standard of care fibrinogen product often used in liver transplant cases. The procedures to use AHF include requesting the order of this product and then waiting for the product to be thawed for use, which can take approximately 10-15 minutes. Subjects assigned to this group will receive all standard of care procedures, including the use of AHF if required during their scheduled surgery.",[13],"Biological: Cryoprecipitate Antihemophilic Factor (AHF)",{"label":15,"type":10,"description":16,"interventionNames":17},"Intercept Fibrinogen Complex (IFC)","IFC is an approved fibrinogen product that is not typically stored in the OR for liver transplant cases. Subjects assigned to this group will receive standard of care procedures, with the addition of IFC being readily available in their designated OR to eliminate any delay if they are to require the use of a fibrinogen product.",[18],"Biological: Intercept Fibrinogen Complex (IFC)",[20,25],{"type":21,"name":15,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","INTERCEPT Fibrinogen Complex is a pathogen-reduced cryoprecipitated fibrinogen complex derived from human plasma. It contains fibrinogen, Factor XIII, and von Willebrand factor to achieve stable clot formation and restore hemostasis. Recently approved by the US Food and Drug Administration, it is used for the treatment of bleeding associated with fibrinogen deficiency.",[15],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Cryoprecipitate Antihemophilic Factor (AHF)","Cryoprecipitate Antihemophilic Factor (AHF), also known as cryo, is a frozen blood product prepared from blood plasma. It is used for fibrinogen supplementation, particularly for hypofibrinogenemia fibrinogen, anemia associated with bleeding or congenital deficiency.",[9],[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Meghan Huff Research Nurse, BSN","CONTACT","6185789309","mhuff@pitt.edu",[36],{"facility":37,"status":24,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of Cincinnati","Cincinnati","Ohio","45221","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-84.51439,39.12711,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":24,"email":53},"Ralph Quillin","513-558-3993","quillirc@ucmail.uc.edu",{"type":55,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100613381","phase-4-fibrinogen-in-liver-transplant-100613381",false,"NCT07265843","Fibrinogen in Liver Transplant","Fibrinogen in Liver Transplant Subjects (FITS)","Inclusion Criteria:\n\n* 18 years of age or older\n* Scheduled to undergo cadaveric liver transplant\n* Meets at least one of the following criteria:\n* Baseline fibrinogen \\\u003C200 mg\u002FdL or clinically significant visoelastic testing,\n* Alcoholic cirrhosis,\n* Nonalcoholic Steatohepatitis (NASH),\n* HCV infection\n\nExclusion Criteria:\n\n* Living related donor transplant,\n* Known prothrombotic disorder,\n* Patient objection to blood transfusion,\n* Known severe allergic reaction to plasma-based products,\n* IgA deficiency with known hypersensitivity reaction to plasma,\n* Hepatocellular\u002Fcholangio carcinoma,\n* Primary biliary fibrosis","ALL","18 Years",{"count":66,"type":67},60,"ESTIMATED","INTERVENTIONAL",[70],"PHASE4","The study is a prospective, multi-centered, unblinded, randomized controlled pilot study. The primary objective is to compare functional hemostatic capacity of two approved products Intercept Fibrinogen Complex (IFC) to Standard Cryoprecipitate Antihemophilic Factor (AHF) for liver transplant patients with bleeding and hypofibrinogenemia to determine impact of earlier access to a concentrated source of fibrinogen in a goal-directed manner.",[73],"Liver Transplant Surgery",[75],"Cryoprecipitate","NOT_YET_RECRUITING","2025-12-01",{"date":79,"type":80},"2025-12-05","ACTUAL",{"date":82,"type":67},"2026-01-01",{"date":84,"type":67},"2028-03-01",{"name":5,"class":6},1]