High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Acute Liver Failure

Treatments: Drug: Hypertonic 3% saline; Biological: High Volume Plasma Exchange; Device: Elective positive pressure ventilation; Drug: Mannitol

Study type: Interventional

Funder types: Other

Identifiers

NCT02719210

ILBS-ALF-02

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

High Volume Plasma Exchange with Standard Treatment

Experimental group

Treatment:

Biological: High Volume Plasma Exchange

Standard Treatment

Active Comparator group

Description:

Standard Treatment is defined as anti raised Intra-cranial pressure 1. Elective positive pressure ventilation in hepatic encephalopathy grade 3 or 4 and in those with features of raised ICP (Intra-cranial pressure). 2. Mannitol 3. Hypertonic 3% Saline

Treatment:

Drug: Mannitol

Drug: Hypertonic 3% saline

Device: Elective positive pressure ventilation