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All the children with acute liver failure who are candidates for transplant but have constraints for transplant will be randomized either to receive standard medical therapy or high volume plasma exchange along with standard medical therapy with the aim to assess the effect of high volume plasma exchange on transplant free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Volume Plasma Exchange with Standard Treatment | Experimental |
| |
| Standard Treatment | Active Comparator | Standard Treatment is defined as anti raised Intra-cranial pressure
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Volume Plasma Exchange | Biological |
| ||
| Hypertonic 3% saline |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant free Survival. | 7 days | |
| Transplant free survival | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Survival after liver transplant with or without High Volume Plasma Exchange. | 30 days post procedure | |
| Incidence of organ dysfunction (other than liver and Central Nervous System). | 30 days | |
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Inclusion Criteria:
- Children ≥ 10kg with ALF with INR ≥ 4 or INR ≥ 3 with Hepatic Encephalopathy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Arti Pawaria, MD | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Drug |
|
| Mannitol | Drug |
|
| Elective positive pressure ventilation | Device |
|
| Number of organs (other than liver and CNS) affected in children with organ dysfunction. |
| 30 days |
| Incidence of High Volume Plasma Exchange related complications- Major/Minor. | within 1 month |
| Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group. | 0 day |
| Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group. | 5 days |
| Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group. | 0 day |
| Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group. | 5 day |
| Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in HVPE arm from baseline till within 24-hours of the last session of High Volume Plasma Exchange. | within 24-hours of the last session of High Volume Plasma Exchange |
| Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in control arm from baseline till 5 days. | 5 days |
| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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