Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Location status: Recruiting
NCT Number: NCT06831643
Acute liver failure is a multisystem disorder characterized by a syndrome of jaundice, coagulopathy, and encephalopathy with high mortality in the absence of liver transplantation. The pathogenesis of multiorgan failure (MOF) in ALF has been attributed to the release of damage-associated molecular patterns (DAMPs) from injured hepatic cells and microbial pathogen-associated molecular patterns (PAMPs) in the presence of superimposed infection or bacterial translocation.The innate immune cells activated by PAMPs and DAMPs produce pro-inflammatory cytokines [interleukin (IL)-6, IL-1b, IL-8, tumor necrosis factor-alpha (TNF-a)]. Studies indicate that the removal of inflammatory mediators appears to play a role in the treatment of ALF and are removed by some apheresis techniques. Hence therapeutic exchange (TPE) has been used as adjunct or standalone therapy for bridging patients to recovery or LT. TPE to treat liver failure involves two steps-removal of plasma from a patient with liver failure and replacing this with equal volume of fluid; in view of the coagulopathy seen in liver failure patients, the preferred fluid for replacement is fresh frozen plasma. Different doses of PLEX have been used to treat liver failure patients with high, standard or low volume PLEX, to treat ALF. Presently American Apheresis Society guidelines consider High Volume TPE (HV-TPE) as first line the management of ALF. But HV-TPE, apart from strain on blood bank resources (large volumes of fresh frozen plasma needed), also carries risk of transfusion associated acute lung complications, risk of blood borne virus infection, and so on make the use of low-volume PLEX attractive compared to high-volume PLEX. Hence this study is being carried out to consider the safety and efficacy of standard volume plasma exchange (SV-TPE) vs. HV-TPE in Pediatric ALF.
Interested in participating?
Request Info3 year–18 year
All sexes
Interventional
Not applicable
New Delhi, National Capital Territory of Delhi, 110070, India
Location status: Recruiting
Aim: To study the efficacy in terms of the native liver survival, of standard volume plasma exchange as compared to high volume plasma exchange in Pediatric ALF.
Study Design: Open label pilot Randomized Control trial. Sample size: Time bound. All cases presenting during the study period will be included in the study.
Standard Medical Therapy:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard Medical treatment
Therapeutic Plasma Excahnge
Time frame: Day 21
Time frame: Day 0,Day1,Day2,day3,Day 4
Time frame: Day 0,Day1,Day2,day3,Day 4
Time frame: Day 0,Day1,Day2,day3,Day 4
Time frame: Day 0,Day1,Day2,day3,Day 4
Time frame: Day 0,Day1,Day2,day3,Day 4
Time frame: Day 0,Day1,Day2,day3,Day 4
Time frame: Day 0,Day1,Day2,day3,Day 4
Time frame: Day 0 & Day 3
Time frame: Day 0 & Day 3
Time frame: Day 0 & Day 3
Time frame: Day 0 & Day 3
Time frame: Within Day 21
Time frame: Within Day 21
Time frame: Within Day 21
Time frame: Within Day 21
Contact information is provided by the study sponsor or research team.
Dr Ashray S Patel, MD
CONTACT
Dr Vikrant Sood, DM
CONTACT
Institute of Liver and Biliary Sciences, India
Other
Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure - A Pilot Randomized Control Trial
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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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