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NCT Number: NCT06187220

Plasma Exchange for Amanita Toxin-induced Acute Liver Failure

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.

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Key information

Conditions

Acute Liver Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute

Age range

0 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Aachen (RWTH), Aachen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic Plasma Exchange (PEX)

Device

Therapeutic plasma exchange with treatment sessions >=1 replacing varying fractions of patient´s whole plasma with healthy donor plasma

Primary outcomes

  1. Liver Transplant free Survival

    Time frame: 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 outcomes

  1. Overall Survival

    Time frame: 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)

  2. Liver transplantation

    Time frame: 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)

  3. High urgency (HU) listing for liver transplantation

    Time frame: 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)

  4. Acute kidney injury (AKI) and max. grade of AKI (I-III)

    Time frame: 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)

  5. Renal Replacement Therapy (RRT)

    Time frame: 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)

  6. Vasopressor therapy

    Time frame: 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)

  7. Invasive ventilation

    Time frame: 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)

  8. Maximum grade of hepatic encephalopathy (HE)

    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) until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5)

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

Effect of Therapeutic Plasma Exchange on Liver Transplantation-free Survival in Amanita Toxin-induced Acute Liver Failure - a Multicenter Retrospective Study Over 10 Years

Acronym: Amanita-Pex

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 2, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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