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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.
Therapeutic Plasma Exchange is associated with risk of adverse events like infections,Fluid overload or circulatory insufficiency, Hypersensitivity to blood products.
- Stopping rule: Study will be stopped in case of life- threatening events occur in patient after randomisation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasma Exchange | Experimental | 3 to 5 sessions +Steroids |
|
| Standard Medical Treatment | Active Comparator | Steroids + Nutrition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma Exchange | Biological | 3 to 5 sessions alternate day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with change in AST,ALT,Bilirubin | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Liver transplant free survival at 28 days. | 28 days | |
| Development of adverse event due to TPE | 28 days | |
| Number of patients with development of clinical infection during study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr J.Gnana Kavitha, MD | Contact | 09717270640 | drkavitha777@gmail.com | |
| Dr Satender Pal Singh, DM | Contact | 01146300000 | ama.satender@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences (ILBS) | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D019693 | Hepatitis, Autoimmune |
| ID | Term |
|---|---|
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010951 | Plasma Exchange |
| D013256 | Steroids |
| D004032 | Diet |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
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| Steroid |
| Drug |
Steroid |
|
| Diet | Dietary Supplement | Diet |
|
Clinical infections includes pneumonia, SBP,UTI,soft tissue infections,blood stream infections. |
| 28 days |
| Mortality during hospital stay | 28 days |
| Change in grade of HE, grade of ascites (both ascites and HE if present). | 28 days |
| Frequency of decompensation events on follow up period. | 28 days |
| Infections at 28 days | 28 days |
| D001327 |
| Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001781 |
| Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |