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New treatment option for Acute Liver Failure
Official title Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure
ClinicalTrials.gov ID: NCT06831643
What this study is testing
What is Standard Medical treatment?
Standard Medical treatment is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute liver failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)].
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 18
You may be able to join if
- Age: 3 years to 18 years
- Fulfilling PALFSG definition (J Pediatr. 2006 May;148(5):652-658).
- Baseline INR ≥ 2.5, and increasing INR (any value) and/or worsening hepatic. encephalopathy (\> 1 grade change) after 6 to 12 hours of standard...
You likely can't join if
- Disseminated intravascular coagulation
- Marked hemodynamic instability requiring a high dose of vasopressors (norepinephrine \>0.5 mcg/kg/min)
- Signs of irreversible brain injury
- Any severe cardio-pulmonary pre-existing disease
- Septic Shock
The study team makes the final eligibility decision.
Where it's taking place
- New Delhi, National Capital Territory of Delhi, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Delhi, National Capital Territory of Delhi, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.