protocolSection identificationModule nctId: NCT06355726, orgStudyIdInfo id: ILBS-Alcoholic Hepatitis-03, briefTitle: Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Institute of Liver and Biliary Sciences, India, class: OTHER, descriptionModule briefSummary: Alcoholic hepatitis, the most florid form of alcoholic liver disease, has a very high short-term mortality of up to 50% and no specific therapies are available other than steroids. Steroids also only show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits. Additionally, only a small proportion of patients with alcoholic hepatitis are eligible to receive steroids. Thus, a large number of patients are either not eligible or do not respond to steroids and this group outnumbers those who do respond to steroids, leaving us without any specific therapeutic options for a majority of these individuals.\[1\] Even liver transplantation is not feasible in most cases due to the presence of sepsis or recent alcohol consumption and many ethical and logistic issues are involved despite the documented safety and survival benefits of early liver transplantation in patients with severe alcoholic hepatitis (SAH) not responding to medical management.\[2,8\] Therefore, newer, more effective, and nontransplant therapeutic options for managing severe alcoholic hepatitis are needed. TPE is expected to be an effective and well-tolerated bridge therapy in patients with severe alcoholic hepatitis of moderate severity not improving on SMT and without immediate prospects for liver transplantation., conditionsModule conditions: Alcoholic Hepatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Plasma Exchange, interventions name: Standard Medical Treatment, outcomesModule primaryOutcomes measure: Liver transplant free survival at 28 days, 90 days and 180 days., secondaryOutcomes measure: Change in total bilirubin and INR as measured by Discriminant Functions, secondaryOutcomes measure: Number of patients with change in Model for End Stage Liver Disease (MELD), secondaryOutcomes measure: Number of patients with change in CTP, secondaryOutcomes measure: Number of patients with change in LSM,SSM, secondaryOutcomes measure: Mortality in both groups, secondaryOutcomes measure: clinical improvement in the form of jaundice as measured by total bilirubin, secondaryOutcomes measure: clinical improvement in the form of hepatic encephalopathy as measured by west haven criteria, secondaryOutcomes measure: clinical improvement in the form of ascites as measured by ICA criteria., secondaryOutcomes measure: Frequency of decompensation events on follow up period, secondaryOutcomes measure: Adverse events during plasma exchange, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Institute of Liver & Biliary Sciences (ILBS), city: New Delhi, state: Delhi, zip: 110070, country: India, geoPoint lat: 28.63576, lon: 77.22445, hasResults: False