NCT06187220

Plasma Exchange for Amanita Toxin-induced Acute Liver Failure

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 111 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 0 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Liver Failure

Interventions

Type	Name	Description
DEVICE	Therapeutic Plasma Exchange (PEX)	Therapeutic plasma exchange with treatment sessions \>=1 replacing varying fractions of patient´s whole plasma with healthy donor plasma

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-03-10
• Completion: 2025-03-10
• First posted: 2024-01-02
• Last updated: 2025-03-12

Locations

6 sites across 5 countries: Germany, Italy, Mexico, Portugal, Spain