Acute Liver Failure
Conditions
Keywords
Liver Failure, Amanita Toxin, Plasmapheresis, Liver Transplantation
Brief summary
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.
Detailed description
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.
Interventions
DEVICETherapeutic Plasma Exchange (PEX)
Therapeutic plasma exchange with treatment sessions \>=1 replacing varying fractions of patient´s whole plasma with healthy donor plasma
Sponsors
Hannover Medical School
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Acute liver failure (presence of hepatic encephalopathy of grade I or higher and a coagulopathy with an INR \> 1.5) * Amanita Toxin related acute liver failure
Exclusion criteria
* Acute liver failure of other reason than Amanita Toxin * Amanita Toxin associated Hepatitis or severe hepatitis without fulfilling the criteria of acute liver failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Transplant free Survival | until day 28 from initial diagnosis of acute liver failure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver transplantation | until day 28 from initial diagnosis of acute liver failure | Liver transplantation until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR \> 1.5) |
| High urgency (HU) listing for liver transplantation | until day 28 from initial diagnosis of acute liver failure | 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) |
| Acute kidney injury (AKI) and max. grade of AKI (I-III) | until day 28 from initial diagnosis of acute liver failure | 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) |
| Overall Survival | until day 28 from initial diagnosis of acute liver failure | Survival until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with International normalized ratio (INR) \> 1.5) |
| Vasopressor therapy | until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5) | Initiated vasopressor therapy until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR \> 1.5) |
| Invasive ventilation | until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5) | Initiated invasive ventilation 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) | 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) until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR \> 1.5) |
| Renal Replacement Therapy (RRT) | until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5) | Initiated renal replacement therapy until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR \> 1.5) |
Countries
Germany, Italy, Mexico, Portugal, Spain
Outcome results
None listed