[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549113":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":34,"armGroups":35,"interventions":46,"overallOfficials":30,"centralContacts":56,"locations":62,"responsibleParty":77,"collaborators":30,"id":79,"slug":30,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":30,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":30,"enrollmentInfo":87,"targetDuration":30,"studyType":90,"phases":30,"briefSummary":91,"conditions":92,"keywords":30,"overallStatus":65,"whyStopped":30,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Octapharma","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"TEEs within 45 days following VKA reversal treatment","Proportion of subjects diagnosed with TEEs within 45 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects diagnosed with TEEs within the same period following VKA reversal treatment with Kcentra.","45 days",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"TEEs within 7 and 14 days following VKA reversal treatment","Proportion of subjects diagnosed with TEEs within 7 and 14 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects diagnosed with TEEs within the same period following VKA reversal treatment with Kcentra.","14 days",{"measure":19,"description":20,"timeFrame":12},"Median Time to TEEs","Median time to TEE following administration of BALFAXAR compared to median time to TEE following administration of Kcentra",{"measure":22,"description":23,"timeFrame":12},"All Cause Mortality","Proportion of subjects who die from any reason within 7, 14 and 45 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects who die from any reason within the same time period following treatment with Kcentra.",{"measure":25,"description":26,"timeFrame":12},"Median Time to All Cause Mortality","Median time to death following administration of BALFAXAR compared to median time to death following administration of Kcentra",{"measure":28,"description":29,"timeFrame":12},"Rate of Fatal TEEs","Rate of fatal TEEs following treatment with BALFAXAR compared to rate of fatal TEEs following treatment with Kcentra within 7, 14 and 45 days following VKA reversal treatment",null,{"allocation":30,"interventionModel":30,"interventionModelDescription":30,"primaryPurpose":30,"observationalModel":32,"timePerspective":33,"maskingInfo":30},"COHORT","PROSPECTIVE","Patients at least 18 years of age who are currently on Vitamin K Antagonist treatments and received BALFAXAR or Kcentra for urgent reversal of VKA therapy within 48 hours prior to urgent surgery or invasive procedure. Octapharma will not actively enroll any of the 3,574 projected subjects into the study. Subjects meeting the minimum inclusion and exclusion criteria during the course of routine practice will be added to the study on a monthly basis until the sample size required for the analysis is achieved in each group.",[36,41],{"label":37,"type":30,"description":38,"interventionNames":39},"BALFAXAR® (500 IU)","BALFAXAR will be administered by intravenous (IV) infusion at a rate of 0.12 mL\u002Fkg\u002Fmin (\\~3 units\u002Fkg\u002Fmin), up to a maximum rate of 8.4 mL\u002Fmin (\\~210 units\u002Fmin). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight",[40],"Drug: Balfaxar",{"label":42,"type":30,"description":43,"interventionNames":44},"Kcentra® (500 IU)","KCENTRA will be administered by intravenous infusion at of 0.12 mL\u002Fkg\u002Fmin (\\~3 units\u002Fkg\u002Fmin) up to a maximum rate of 8.4 mL\u002Fmin (\\~210 units\u002Fmin). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight.",[45],"Drug: Kcentra",[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":30},"DRUG","Balfaxar","BALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery\u002Finvasive procedure",[37],{"type":48,"name":53,"description":54,"armGroupLabels":55,"otherNames":30},"Kcentra","KCENTRA, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with:\n\n* acute major bleeding or\n* need for an urgent surgery\u002Finvasive procedure",[42],[57],{"name":58,"role":59,"phone":60,"phoneExt":30,"email":61},"Patrick Murphy","CONTACT","8663371868","p.murphy@crmg-usa.com",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":30},"Octapharma Research Site","RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-71.05977,42.35843,{"lat":75,"lon":74},{"type":78,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100549113",false,"NCT06429787","Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure","Post Marketing Observational Study on Safety of BALFAXAR® vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure.","Inclusion Criteria:\n\n1. Subjects at least 18 years of age.\n2. Subjects on VKA treatment.\n3. Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure.\n\nExclusion Criteria:\n\n1. History of TEE within 90 days before receipt of VKA reversal therapy.\n2. Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.","ALL","18 Years",{"count":88,"type":89},3574,"ESTIMATED","OBSERVATIONAL","Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure",[93,94],"Vitamin K-Dependent Coagulation Defect","Significant Bleeding Risk","2025-06-03",{"date":97,"type":98},"2025-06-04","ACTUAL",{"date":100,"type":98},"2025-02-14",{"date":102,"type":89},"2032-06-30",{"name":5,"class":6},1]