Plasma Exchange for Amanita Toxin-induced Acute Liver Failure

NCT06187220 | Completed

• 1 other identifier: Amanita-Pex
• Study Type: observational
• Target: 111
• Locations: 5 countries
• Sites: 6

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.

Conditions

Acute Liver Failure

Keywords

Liver Failure; Amanita Toxin; Plasmapheresis; Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• Liver Transplant free Survival

  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)

  until day 28 from initial diagnosis of acute liver failure

Secondary Outcomes (8)

• Overall Survival

  until day 28 from initial diagnosis of acute liver failure

• Liver transplantation

  until day 28 from initial diagnosis of acute liver failure

• High urgency (HU) listing for liver transplantation

  until day 28 from initial diagnosis of acute liver failure

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

  until day 28 from initial diagnosis of acute liver failure

• Renal Replacement Therapy (RRT)

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

Study Arms (2)

Therapeutic Plasma Exchange (PEX)

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

Device: Therapeutic Plasma Exchange (PEX)

Standard Medical Therapy (SMT)

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.

Interventions

Therapeutic Plasma Exchange (PEX) DEVICE

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

Therapeutic Plasma Exchange (PEX)

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with Amanita toxin related acute liver failure, both adult and pediatric

You may qualify if:

• 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

You may not qualify if:

• Acute liver failure of other reason than Amanita Toxin
• Amanita Toxin associated Hepatitis or severe hepatitis without fulfilling the criteria of acute liver failure

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (6)

University Hospital Aachen (RWTH)

Aachen, Germany

Location

Hannover Medical School

Hanover, Germany

Location

ASST Ospedale Papa Giovanni XXIII

Bergamo, Italy

Location

INCMNSZ

Mexico City, Mexico

Location

Curry Cabral Hospital

Lisbon, Portugal

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Related Publications (3)

• Stahl K, Hadem J, Schneider A, Manns MP, Wiesner O, Schmidt BMW, Hoeper MM, Busch M, David S. Therapeutic plasma exchange in acute liver failure. J Clin Apher. 2019 Oct;34(5):589-597. doi: 10.1002/jca.21737. Epub 2019 Jul 26.

  PMID: 31348553 BACKGROUND

• Stahl K, Bode C, David S. Bridging patients with acute-on-chronic liver failure for transplantation: plasma exchange to stabilize multiorgan failure? Intensive Care Med. 2023 Jul;49(7):890-891. doi: 10.1007/s00134-023-07092-x. Epub 2023 May 13. No abstract available.

  PMID: 37178148 BACKGROUND

• Stahl K, Busch M, Fuge J, Schneider A, Manns MP, Seeliger B, Schmidt JJ, Wiesner O, Schmidt BMW, Taubert R, Vondran FWR, Hoeper MM, David S. Therapeutic plasma exchange in acute on chronic liver failure. J Clin Apher. 2020 Aug;35(4):316-327. doi: 10.1002/jca.21799. Epub 2020 Jun 24.

  PMID: 32583446 BACKGROUND

MeSH Terms

Conditions

Liver Failure, Acute; Liver Failure

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Klaus Stahl, MD

  Hannover Medical School, Hannover Germany

  PRINCIPAL INVESTIGATOR

• Richard Taubert, MD

  Hannover Medical School, Hannover Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Klaus Stahl, PD Dr. Richard Taubert, Dr. Bahar Nalbant

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 2, 2024
• Study Start: January 1, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

ES (1); IT (1); PT (1); DE (2); ME (1)