[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549113":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Octapharma","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BALFAXAR® (500 IU)",null,"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",[13],"Drug: Balfaxar",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[18],"Drug: Kcentra",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"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",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"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",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Patrick Murphy","CONTACT","8663371868","p.murphy@crmg-usa.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":10},"Octapharma Research Site","RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-71.05977,42.35843,{"lat":48,"lon":47},{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100549113","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-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":62,"type":63},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",[67,68],"Vitamin K-Dependent Coagulation Defect","Significant Bleeding Risk","2025-06-03",{"date":71,"type":72},"2025-06-04","ACTUAL",{"date":74,"type":72},"2025-02-14",{"date":76,"type":63},"2032-06-30",{"name":5,"class":6},1]