[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555673":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":39,"responsibleParty":53,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":81,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High Volume Therapeutic plasma Exchange","EXPERIMENTAL","The high - volume strategy would be performed by centrifugation technique \\~ 8 - 9 litres of plasma would be exchanged in each patient over 6 - 8 hours along with Standard Medical Treatment",[13],"Procedure: High Volume Therapeutic Plasma Exchange",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard volume Therapeutic Plasma Exchange","ACTIVE_COMPARATOR","The standard volume strategy would be performed centrifugation technique with Plasma volume varying from 1.5 - 2.5 times the plasma - volume along with Standard Medical Treatment.",[19],"Procedure: Standard volume therapeutic plasma exchange",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","High Volume Therapeutic Plasma Exchange","Experimental- High Volume Therapeutic Plasma Exchange at (8 - 9 litres of plasma would be exchanged in each patient over 6 - 8 hours)",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard volume therapeutic plasma exchange","Active Comparator - The standard volume strategy would be performed centrifugation technique with Plasma volume varying from 1.5 - 2.5 times the plasma - volume along with Standard Medical Treatment.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Dr. Rakhi Maiwall, DM","CONTACT","01146300000","rakhi_2011@yahoo.co.in",{"name":38,"role":34,"phone":35,"phoneExt":26,"email":36},"Dr Rakhi Maiwall, DM",[40],{"facility":41,"status":26,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":26},"Institute of Liver & Biliary Sciences","New Delhi","National Capital Territory of Delhi","110070","India","IN",{"type":48,"coordinates":49},"Point",[50,51],77.2148,28.62137,{"lat":51,"lon":50},{"type":54,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100555673","high-volume-versus-standard-volume-plasma-exchange-in-patients-with-acute-liver-failure-with-cerebral-edema-100555673",false,"NCT06515145","High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema","To Evaluate the Safety and Efficacy of High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema -A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\nPatients with acute liver failure defined as patients with jaundice which is complicated by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without underlying chronic liver disease.\n\nCerebral edema documented on CT-scan and arterial ammonia \\>150 ug\u002FdL\n\nExclusion Criteria:\n\n1. Age \\\u003C18 or \\> 70 years\n2. HCC\n3. Active untreated Sepsis\u002FDIC\n4. Hemodynamic instability non-responsive to initial fluid resuscitation with norepinephrine \\>0.1 ug\u002Fkg\u002Fmin\n5. Post-resection and malignancy related liver failure\n6. Coma of non-hepatic origin\n7. Patients with uncontrolled infection\n8. Patients with pulmonary involvement with Pa02\u002FFio2 ratio below 200.\n9. Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis\n10. Extremely moribund patients with an expected life expectancy of less than 24 hours\n11. Pregnancy related liver failure\n12. Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score \\>3, or oxygen\u002Fsteroid-dependent chronic obstructive pulmonary disease)\n13. Refusal to participate in the study\n14. Drug-induced ALF","ALL","18 Years","70 Years",{"count":66,"type":67},60,"ESTIMATED","INTERVENTIONAL",[70],"NA","In this prospective randomized controlled trial Investigator aim to evaluate the impact of high versus standard volume plasma-exchange in patients with acute liver failure with cerebral edema and clinical outcomes. ALF who meet the inclusion and exclusion criteria within the first 12 hours will be randomized into two groups\n\nInterventional - High-volume plasma exchange Active Comparator - Standard volume plasma exchange\n\nExpected outcome of the project-.\n\n1. Primary end points: Time to improvement in cerebral edema\n2. Secondary end points:\n\nTo study the adverse events of therapy (volume overload, pulmonary complications, allergic reactions) etc.\n\nTransplant-free survival at day 21",[73,74],"Acute Liver Failure","Cerebral Edema",[76,77,78,79,80],"Plasma-exchange","systemic inflammatory response syndrome","lactate","CRRT","sepsis","NOT_YET_RECRUITING","2025-09-18",{"date":84,"type":85},"2025-09-19","ACTUAL",{"date":87,"type":67},"2025-12-01",{"date":89,"type":67},"2026-03-01",{"name":5,"class":6},1]