Plasma Exchange for Amanita Toxin-induced Acute Liver Failure (Amanita-Pex)

Hannover Medical School (MHH)

Status: Completed

Conditions: Acute Liver Failure

Treatments: Device: Therapeutic Plasma Exchange (PEX)

Study type: Observational

Funder types: Other

Identifiers

NCT06187220

Amanita-Pex

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

111 participants in 2 patient groups

Therapeutic Plasma Exchange (PEX)

Description:

Patients receiving in addition to Standard Medical Therapy (SMT) at least one treatment with Therapeutic Plasma Exchange (PEX)

Treatment:

Device: Therapeutic Plasma Exchange (PEX)

Standard Medical Therapy (SMT)

Description:

Patients receiving only Standard Medical Therapy (SMT) of Amanita Toxin associated acute liver failure, including intensive care support (invasive ventilation, vasopressors, renal replacement therapy), silibinin and n-acetylcystein. Included in this group are also patients receiving albumine dialysis or other extracorporeal liver assist therapies excluding therapeutic plasma exchange.