Clinical Trial: High Volume Plasma Exchange in Children With Acute Liver Failure

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: High Volume Plasma Exchange in Children With Acute Liver Failure-A Prospective Randomized Controlled Trial.

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.

Detailed Summary:
Sponsor: Institute of Liver and Biliary Sciences, India

Current Primary Outcome:

  • Transplant free Survival. [ Time Frame: 7 days ]
  • Transplant free survival [ Time Frame: 30 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Survival after liver transplant with or without High Volume Plasma Exchange. [ Time Frame: 30 days post procedure ]
  • Incidence of organ dysfunction (other than liver and Central Nervous System). [ Time Frame: 30 days ]
  • Number of organs (other than liver and CNS) affected in children with organ dysfunction. [ Time Frame: 30 days ]
  • Incidence of High Volume Plasma Exchange related complications- Major/Minor. [ Time Frame: within 1 month ]
  • Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group. [ Time Frame: 0 day ]
  • Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group. [ Time Frame: 5 days ]
  • Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group. [ Time Frame: 0 day ]
  • Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 5 days ]


Original Secondary Outcome:

  • Survival after liver transplant with or without High Volume Plasma Exchange. [ Time Frame: 30 days post procedure ]
  • Incidence of organ dysfunction (other than liver and Central Nervous System). [ Time Frame: 30 days ]
  • Number of organs (other than liver and CNS) affected in children with organ dysfunction. [ Time Frame: 30 days ]
  • Incidence of High Volume Plasma Exchange related complications- Major/Minor. [ Time Frame: within 1 month ]
  • Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group group. [ Time Frame: 0 day ]
  • Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group. [ Time Frame: 5 days ]
  • Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group. [ Time Frame: 0 day ]
  • Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 5 days ]


Information By: Institute of Liver and Biliary Sciences, India

Dates:
Date Received: February 17, 2016
Date Started: January 2016
Date Completion: December 2017
Last Updated: December 17, 2016
Last Verified: December 2016