Clinical trial NCT02719210: High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure
Official title: High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure-A Prospective Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 75
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Transplant free Survival.
timeFrame: 7 days
measure: Transplant free survival
timeFrame: 30 days
Secondary outcomes:
measure: Survival after liver transplant with or without High Volume Plasma Exchange.
timeFrame: 30 days post procedure
measure: Incidence of organ dysfunction (other than liver and Central Nervous System).
timeFrame: 30 days
measure: Number of organs (other than liver and CNS) affected in children with organ dysfunction.
timeFrame: 30 days
measure: Incidence of High Volume Plasma Exchange related complications- Major/Minor.
timeFrame: within 1 month
measure: Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
timeFrame: 0 day
measure: Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
timeFrame: 5 days
measure: Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group.
timeFrame: 0 day
measure: Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group.
timeFrame: 5 day
measure: 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.
timeFrame: within 24-hours of the last session of High Volume Plasma Exchange
measure: Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in control arm from baseline till 5 days.
timeFrame: 5 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Arti Pawaria, MD
role: PRINCIPAL_INVESTIGATOR
References: