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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Transplant free Survival.
Time frame: 7 days
Transplant free survival
Time frame: 30 days
Survival after liver transplant with or without High Volume Plasma Exchange.
Time frame: 30 days post procedure
Incidence of organ dysfunction (other than liver and Central Nervous System).
Time frame: 30 days
Number of organs (other than liver and CNS) affected in children with organ dysfunction.
Time frame: 30 days
Incidence of High Volume Plasma Exchange related complications- Major/Minor.
Time frame: within 1 month
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
Time frame: 0 day
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
Time frame: 5 days
Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group.
Time frame: 0 day
Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group.
Time frame: 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.
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Time frame: 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.
Time frame: 5 days