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

High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure-A Prospective Pilot Study.

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 Overview

• Status: Completed
• Conditions: Acute Liver Failure
• Intervention / Treatment: Drug: Mannitol; Biological: High Volume Plasma Exchange; Drug: Hypertonic 3% saline; Device: Elective positive pressure ventilation

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Volume Plasma Exchange with Standard Treatment	Biological: High Volume Plasma Exchange
Active Comparator: Standard Treatment; Standard Treatment is defined as anti raised Intra-cranial pressure; Elective positive pressure ventilation in hepatic encephalopathy grade 3 or 4 and in those with features of raised ICP (Intra-cranial pressure).; Mannitol; Hypertonic 3% Saline	Drug: Mannitol; Drug: Hypertonic 3% saline; Device: Elective positive pressure ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Transplant free Survival.	7 days
Transplant free survival	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Survival after liver transplant with or without High Volume Plasma Exchange.	30 days post procedure
Incidence of organ dysfunction (other than liver and Central Nervous System).	30 days
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
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.	5 days
Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group.	0 day
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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Dr Arti Pawaria, MD, Institute of liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Liver Failure, Acute; Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: ILBS-ALF-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided