About this trial
Autoimmune hepatitis (AIH) is a chronic inflammatory liver disease that can lead to cirrhosis and liver failure. AIH can present in all ages, races, and ethnicities, but it mostly affects women. As a heterogeneous disease, AIH presents variably in different patients, making diagnosis and treatment a challenge.It is associated with varied clinical presentations and natural history and somewhat unpredictable treatment responses. Steroids and immunosupressants are main stay of treatment.In acute severe presentations corticosteroid response rates are more variable.According to treatment guidelines if patients fail to respond to corticosteroids, Liver transplant is the only option. But Liver transplant is not feasible in all situations such as limited donor availability.Plasma exchange is associated with a reduction in levels of pro-inflammatory cytokines,DAMPs, and bacterial endotoxins and increase in the levels of anti-inflammatory cytokines.Plasma exchange has reportedly been used for acute presentations of AIH but there are few trials which prove its independent benefit and role in influencing transplant free survival.The study aims at proving the efficacy of Plasma exchange as a bridge between steroid therapy and Liver transplant.It includes the patients with acute severe autoimmune hepatitis .One group of patients are taken up for plasma exchange sessions and compared with the other group started on high dose of steroids and they will be observed for 28 days and are assessed for transplant free survival and efficacy of plasma exchange in reducing transaminitis and Bilirubin levels.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-60 years
Acute severe autoimmune hepatitis with MELD >24
No liver transplant option < 28 days.
-ACLF + Non ACLF
Disqualifiers
Patients with Active sepsis
Patients with Active bleeding
Patients allergic to FFP and blood products
Patients with unstable hemodynamics ( eg:BP<90/60 mmhg,HR >100bpm)
Trial design
Parallel
Treatments tested in this trial
Plasma Exchange
Biological/Vaccine3 to 5 sessions alternate day
Steroid
DrugSteroid
Diet
Dietary supplementDiet
Treatment groups
Trial outcomes
Primary outcomes
Number of patients with change in AST,ALT,Bilirubin
Secondary outcomes
Liver transplant free survival at 28 days.
Development of adverse event due to TPE
Number of patients with development of clinical infection during study period
Clinical infections includes pneumonia, SBP,UTI,soft tissue infections,blood stream infections.
Mortality during hospital stay
Sponsors and contacts
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