Acute Liver Failure
Conditions
Brief summary
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.
Interventions
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
\- Children ≥ 10kg with ALF with INR ≥ 4 or INR ≥ 3 with Hepatic Encephalopathy.
Exclusion criteria
1. Evidence of active infection (Age specific neutrophilic leucocytosis (ANC) and procalcitonin ≥ 2 and/or focus of active infection 2. Refusal of consent or assent (annexure 3) 3. Liver resections with liver failure 4. Patients with clinical suspicion of irreversible brain injury 5. Patients with acute kidney injury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transplant free Survival. | 7 days |
| Transplant free survival | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Survival after liver transplant with or without High Volume Plasma Exchange. | 30 days post procedure |
| 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 |
| Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group. | 0 day |
| Incidence of organ dysfunction (other than liver and Central Nervous System). | 30 days |
Countries
India
Outcome results
None listed