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Completed

NCT Number: NCT02719210

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

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.

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Key information

Conditions

Acute Liver Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Volume Plasma Exchange

Biological

Hypertonic 3% saline

Drug

Mannitol

Drug

Elective positive pressure ventilation

Device

Primary outcomes

  1. Transplant free Survival.

    Time frame: 7 days

  2. Transplant free survival

    Time frame: 30 days

Secondary outcomes

  1. Survival after liver transplant with or without High Volume Plasma Exchange.

    Time frame: 30 days post procedure

  2. Incidence of organ dysfunction (other than liver and Central Nervous System).

    Time frame: 30 days

  3. Number of organs (other than liver and CNS) affected in children with organ dysfunction.

    Time frame: 30 days

  4. Incidence of High Volume Plasma Exchange related complications- Major/Minor.

    Time frame: within 1 month

  5. Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.

    Time frame: 0 day

  6. Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.

    Time frame: 5 days

  7. Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group.

    Time frame: 0 day

  8. Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group.

    Time frame: 5 day

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 25, 2016
Registry last updated
Dec 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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