Plasma Exchange for Amanita Toxin-induced Acute Liver Failure
- Conditions
- Acute Liver Failure
- Interventions
- Device: Therapeutic Plasma Exchange (PEX)
- Registration Number
- NCT06187220
- Lead Sponsor
- Hannover Medical School
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
- 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
- Acute liver failure of other reason than Amanita Toxin
- Amanita Toxin associated Hepatitis or severe hepatitis without fulfilling the criteria of acute liver failure
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Therapeutic Plasma Exchange (PEX) Therapeutic Plasma Exchange (PEX) Patients receiving in addition to Standard Medical Therapy (SMT) at least one treatment with Therapeutic Plasma Exchange (PEX)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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)
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)
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)
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)
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)
Trial Locations
- Locations (6)
University Hospital Aachen (RWTH)
🇩🇪Aachen, Germany
Hannover Medical School
🇩🇪Hannover, Germany
INCMNSZ
🇲🇽Mexico City, Mexico
ASST Ospedale Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Curry Cabral Hospital
🇵🇹Lisbon, Portugal