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

NCT ID: NCT02719210

Last Updated: 2018-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Liver Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Volume Plasma Exchange with Standard Treatment

Group Type EXPERIMENTAL

High Volume Plasma Exchange

Intervention Type BIOLOGICAL

Standard Treatment

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

Group Type ACTIVE_COMPARATOR

Hypertonic 3% saline

Intervention Type DRUG

Mannitol

Intervention Type DRUG

Elective positive pressure ventilation

Intervention Type DEVICE

Interventions

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High Volume Plasma Exchange

Intervention Type BIOLOGICAL

Hypertonic 3% saline

Intervention Type DRUG

Mannitol

Intervention Type DRUG

Elective positive pressure ventilation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Arti Pawaria, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences

Locations

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Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-ALF-02

Identifier Type: -

Identifier Source: org_study_id

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