High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure
Primary Purpose
Acute Liver Failure
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
High Volume Plasma Exchange
Hypertonic 3% saline
Mannitol
Elective positive pressure ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Liver Failure
Eligibility Criteria
Inclusion Criteria:
- Children ≥ 10kg with ALF with INR ≥ 4 or INR ≥ 3 with Hepatic Encephalopathy.
Exclusion Criteria:
- Evidence of active infection (Age specific neutrophilic leucocytosis (ANC) and procalcitonin ≥ 2 and/or focus of active infection
- Refusal of consent or assent (annexure 3)
- Liver resections with liver failure
- Patients with clinical suspicion of irreversible brain injury
- Patients with acute kidney injury
Sites / Locations
- Institute of liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Volume Plasma Exchange with Standard Treatment
Standard Treatment
Arm Description
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
Outcomes
Primary Outcome Measures
Transplant free Survival.
Transplant free survival
Secondary Outcome Measures
Survival after liver transplant with or without High Volume Plasma Exchange.
Incidence of organ dysfunction (other than liver and Central Nervous System).
Number of organs (other than liver and CNS) affected in children with organ dysfunction.
Incidence of High Volume Plasma Exchange related complications- Major/Minor.
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group.
Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group.
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.
Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in control arm from baseline till 5 days.
Full Information
NCT ID
NCT02719210
First Posted
February 17, 2016
Last Updated
December 4, 2018
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT02719210
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Liver Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Volume Plasma Exchange with Standard Treatment
Arm Type
Experimental
Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
High Volume Plasma Exchange
Intervention Type
Drug
Intervention Name(s)
Hypertonic 3% saline
Intervention Type
Drug
Intervention Name(s)
Mannitol
Intervention Type
Device
Intervention Name(s)
Elective positive pressure ventilation
Primary Outcome Measure Information:
Title
Transplant free Survival.
Time Frame
7 days
Title
Transplant free survival
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Survival after liver transplant with or without High Volume Plasma Exchange.
Time Frame
30 days post procedure
Title
Incidence of organ dysfunction (other than liver and Central Nervous System).
Time Frame
30 days
Title
Number of organs (other than liver and CNS) affected in children with organ dysfunction.
Time Frame
30 days
Title
Incidence of High Volume Plasma Exchange related complications- Major/Minor.
Time Frame
within 1 month
Title
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
Time Frame
0 day
Title
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
Time Frame
5 days
Title
Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group.
Time Frame
0 day
Title
Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group.
Time Frame
5 day
Title
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.
Time Frame
within 24-hours of the last session of High Volume Plasma Exchange
Title
Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in control arm from baseline till 5 days.
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Children ≥ 10kg with ALF with INR ≥ 4 or INR ≥ 3 with Hepatic Encephalopathy.
Exclusion Criteria:
Evidence of active infection (Age specific neutrophilic leucocytosis (ANC) and procalcitonin ≥ 2 and/or focus of active infection
Refusal of consent or assent (annexure 3)
Liver resections with liver failure
Patients with clinical suspicion of irreversible brain injury
Patients with acute kidney injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Arti Pawaria, MD
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure
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