Retrospective evaluation of the value of additive therapeutic plasma exchange (PEX) compared to standard medical therapy (SMT) in Amanita toxin-associated acute liver failure in children and adolescents within the last 10 years at a international group of liver transplant centers.
Amanita toxin-associated acute liver failure is a life-threatening condition that can often lead to the need for an emergency liver transplantation. The disease may also be fatal, particularly in patients who are not eligible for a liver transplant due to advanced age or corresponding comorbidities. Therapeutic plasma exchange treatment has been shown to significantly improve patient survival in other cases of acute liver failure and has since become standard treatment for acute liver failure in many, but not all, liver transplant centers. However, no patients with Amanita toxin-associated acute liver failure were included in these cohorts. The hypothesis of the planned study is that an additive therapeutic plasma exchange treatment (PEX) can improve liver transplantation-free survival in these patients compared to standard medical therapy (SMT) alone. Since the therapy procedure in different transplant centers in differs with regard to the use of therapeutic plasma exchange, we are therefore planning a multicenter retrospective comparison of PEX with SMT with regard to transplant-free survival and other clinical endpoints. For this very small cohort of patients with acute liver failure, which also varies in frequency depending on the season and weather conditions, there will certainly never be a sufficiently powered randomized and controlled study. This analysis may change the standard procedure for patients with Amanita toxin-associated acute liver failure.
Study Type
OBSERVATIONAL
Enrollment
111
Therapeutic plasma exchange with treatment sessions \>=1 replacing varying fractions of patient´s whole plasma with healthy donor plasma
University Hospital Aachen (RWTH)
Aachen, Germany
Hannover Medical School
Hanover, Germany
ASST Ospedale Papa Giovanni XXIII
Bergamo, Italy
INCMNSZ
Mexico City, Mexico
Liver Transplant free Survival
Survival and free of liver transplantation until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR \> 1.5)
Time frame: until day 28 from initial diagnosis of acute liver failure
Overall Survival
Survival until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with International normalized ratio (INR) \> 1.5)
Time frame: until day 28 from initial diagnosis of acute liver failure
Liver transplantation
Liver transplantation until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR \> 1.5)
Time frame: until day 28 from initial diagnosis of acute liver failure
High urgency (HU) listing for liver transplantation
Initiated high urgency listing for liver transplantation until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR \> 1.5)
Time frame: until day 28 from initial diagnosis of acute liver failure
Acute kidney injury (AKI) and max. grade of AKI (I-III)
Acute kidney injury and max. grade of AKI (I-III) until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR \> 1.5)
Time frame: until day 28 from initial diagnosis of acute liver failure
Renal Replacement Therapy (RRT)
Initiated renal replacement therapy until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR \> 1.5)
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Curry Cabral Hospital
Lisbon, Portugal
Hospital Clínic de Barcelona
Barcelona, Spain
Time frame: until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5)
Vasopressor therapy
Initiated vasopressor therapy until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR \> 1.5)
Time frame: until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5)
Invasive ventilation
Initiated invasive ventilation until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR \> 1.5)
Time frame: until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5)
Maximum grade of hepatic encephalopathy (HE)
Maximum grade of hepatic encephalopathy (HE) until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR \> 1.5)
Time frame: until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5)