[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563571":3},{"organization":4,"outcomesModule":7,"designInfo":76,"detailedDescription":28,"studyPopulation":28,"armGroups":82,"interventions":93,"overallOfficials":102,"centralContacts":106,"locations":112,"responsibleParty":129,"collaborators":28,"id":131,"slug":28,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":28,"eligibilityCriteria":136,"healthyVolunteers":132,"sex":137,"minAge":138,"maxAge":28,"enrollmentInfo":139,"targetDuration":28,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":115,"whyStopped":28,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"CSL Behring","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of participants with overall hemostatic success","Overall hemostatic success will be assessed by an independent data monitoring and efficacy adjudication committee (IDMEAC). The IDMEAC will assess the overall efficacy based on a composite of intraoperative and postoperative hemostasis using a 4-point scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).","During surgery to 24 hours after surgery",[14,18,22,26,30,32,35,37,39,42,45,48,51,53,55,57,59,62,64,67,70,73],{"measure":15,"description":16,"timeFrame":17},"Number of participants with treatment-emergent (TE): adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs)","The TE AESIs include thromboembolic events, viral transmission\u002Fseroconversion, and anaphylaxis and severe hypersensitivity\u002Fsevere allergic reactions.","Up to 30 days after IV infusion",{"measure":19,"description":20,"timeFrame":21},"Number of participants with intraoperative hemostatic efficacy","Intraoperative hemostatic efficacy will be assessed by the surgeon and anesthesiologist using an objective 4-point hemostatic efficacy scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).","During surgery",{"measure":23,"description":24,"timeFrame":25},"Number of participants with postoperative hemostatic efficacy","Postoperative hemostatic efficacy will be assessed by a hematologist using an objective 4-point hemostatic efficacy scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).","Up to 24 hours after surgery",{"measure":27,"description":28,"timeFrame":29},"Plasma fibrinogen concentration",null,"During surgery, at the end of surgery and up to 24 hours after start of surgery",{"measure":31,"description":28,"timeFrame":29},"Mean total dose of fibrinogen administered",{"measure":33,"description":28,"timeFrame":34},"Number of doses of fibrinogen administered","During surgery, at the end of surgery and up to 72 hours after start of surgery",{"measure":36,"description":28,"timeFrame":21},"Duration of surgery",{"measure":38,"description":28,"timeFrame":21},"Intraoperative blood loss",{"measure":40,"description":41,"timeFrame":21},"Intraoperative requirements for blood products","Blood products include fresh frozen plasma, red blood cells, and platelets.",{"measure":43,"description":28,"timeFrame":44},"Postoperative blood loss","Up to 48 hours after start of surgery",{"measure":46,"description":41,"timeFrame":47},"Postoperative requirements for blood products","Up to 9 days after surgery",{"measure":49,"description":28,"timeFrame":50},"Number of participants with reoperation (for bleeding)","Up to 30 days after surgery",{"measure":52,"description":28,"timeFrame":50},"Number of participants with reoperation (for reasons other than bleeding)",{"measure":54,"description":28,"timeFrame":50},"Duration of mechanical ventilation",{"measure":56,"description":28,"timeFrame":50},"Duration of intensive care unit (ICU) stay",{"measure":58,"description":28,"timeFrame":50},"Duration of hospital stay",{"measure":60,"description":28,"timeFrame":61},"21-day mortality","Up to 21 days after surgery",{"measure":63,"description":28,"timeFrame":50},"In-hospital mortality",{"measure":65,"description":66,"timeFrame":21},"Time between placing the investigational product (IP) order to administration","The following time to event parameters will be assessed: time between when IP is ordered and when IP is ready to administer in the operating room and time between when IP is ordered and start of IP administration.",{"measure":68,"description":28,"timeFrame":69},"Prothrombin time and activated partial thromboplastin time","Up to 8 days after surgery",{"measure":71,"description":72,"timeFrame":69},"Coagulation parameter profile","The following coagulation parameter profiles will be assessed: thrombin generation marker, protein C and S, antithrombin and alpha 2-antiplasmin.",{"measure":74,"description":75,"timeFrame":69},"Coagulation factor profile","The following coagulation factor profiles will be assessed: fibrinogen, factor VIII (FVIII):C, von Willebrand ristocetin cofactor (VWF:Rco) and factor XIII (FXIII).",{"allocation":77,"interventionModel":78,"interventionModelDescription":28,"primaryPurpose":79,"observationalModel":28,"timePerspective":28,"maskingInfo":80},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":81,"maskingDescription":28,"whoMasked":28},"NONE",[83,88],{"label":84,"type":85,"description":28,"interventionNames":86},"CSL511","EXPERIMENTAL",[87],"Biological: CSL511 Fibrinogen concentrate (human)",{"label":89,"type":90,"description":28,"interventionNames":91},"Cryoprecipitate","ACTIVE_COMPARATOR",[92],"Biological: Cryoprecipitate",[94,99],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":28},"BIOLOGICAL","CSL511 Fibrinogen concentrate (human)","CSL511 will be prepared in sterile water for injection and administered as an intravenous (IV) infusion.",[84],{"type":95,"name":89,"description":100,"armGroupLabels":101,"otherNames":28},"Cryoprecipitate will be administered via IV infusion.",[89],[103],{"name":104,"affiliation":5,"role":105},"Study Director","STUDY_DIRECTOR",[107],{"name":108,"role":109,"phone":110,"phoneExt":28,"email":111},"Trial Registration Coordinator","CONTACT","+1 610-878-4697","clinicaltrials@cslbehring.com",[113],{"facility":114,"status":115,"city":116,"state":28,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":126},"Basingstoke and North Hampshire Hospital","RECRUITING","Basingstoke","RG24 9NA","United Kingdom","UK",{"type":121,"coordinates":122},"Point",[123,124],-1.08708,51.26249,{"lat":124,"lon":123},[127],{"name":128,"role":109,"phone":28,"phoneExt":28,"email":28},"Asoke Roy",{"type":130,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100563571",false,"NCT06617897","Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery","A Phase 3, Single-center, Randomized, Controlled Clinical Study to Investigate the Efficacy of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery","Inclusion Criteria:\n\n* • Aged \\>= 18 years at the time of providing written informed consent.\n* • Diagnosis of PMP requiring CRS with HIPEC.\n* • Bleeding risk: Predicted intraoperative blood loss of \\>=2L, assessed within 60 and 100 mins after start of study surgery (assessment made before 2 L of blood is lost)\n\nExclusion Criteria:\n\n* • Confirmed or suspected congenital or acquired coagulation disorder or a prothrombotic disorder\n* • Myocardial infarction, acute coronary syndrome, or stroke within 2 months before study surgery.\n* • Known history of chronic hepatitis.\n* • Clopidogrel or ticagrelor administration within 5 days before study surgery.\n* • Prasugrel administration within 7 days before study surgery.\n* • Oral factor Xa inhibitor administration within 2 days before study surgery.\n* • Glycoprotein IIb \u002F IIIa antagonist administration within 24 hours before study surgery.\n* • Oral direct thrombin inhibitor administration within 3 days before study surgery.\n* • Vitamin K antagonists within 5 days before study surgery.","ALL","18 Years",{"count":140,"type":141},90,"ESTIMATED","INTERVENTIONAL",[144],"PHASE3","This study is a phase 3, prospective, single center, randomized, open label, controlled, parallel arm, interventional study to investigate the efficacy and safety of CSL511, in participants undergoing cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for pseudomyxoma peritonei (PMP) with predicted intraoperative blood loss of greater than or equal to (\\>=) 2 liter (L). Eligible participants will be randomized in a 1:1 ratio to 1 of 2 treatment arms, to receive CSL511 or cryoprecipitate.",[147],"Acquired Fibrinogen Deficiency",[149,150,151,152,153],"Fibrinogen deficiency","Pseudomyxoma peritonei","Cytoreductive surgery","Hyperthermic intraperitoneal chemotherapy","Blood coagulation disorder","2026-03-09",{"date":156,"type":157},"2026-03-11","ACTUAL",{"date":159,"type":157},"2024-10-01",{"date":161,"type":141},"2027-10-29",{"name":5,"class":6},1]