Plasma Exchange for Amanita Toxin-induced Acute Liver Failure

Acute Liver Failure Clinical Trial

— Amanita-Pex  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06187220
• Other study ID #: Amanita-Pex
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: April 2024

Study information

• Verified date: December 2023
• Source: Hannover Medical School
• Contact: Klaus Stahl, MD
• Phone: 0049-15172405294
• Email: stahl.klaus[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Liver Failure
• Hepatic Insufficiency
• Liver Failure
• Liver Failure, Acute

Intervention

Device:
• Therapeutic Plasma Exchange (PEX)
Therapeutic plasma exchange with treatment sessions >=1 replacing varying fractions of patient´s whole plasma with healthy donor plasma

Locations

Country	Name	City	State
Germany	University Hospital Aachen (RWTH)	Aachen
Germany	Hannover Medical School	Hannover
Italy	ASST Ospedale Papa Giovanni XXIII	Bergamo
Mexico	INCMNSZ	Mexico City
Portugal	Curry Cabral Hospital	Lisbon
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Countries where clinical trial is conducted

Germany,  Italy,  Mexico,  Portugal,  Spain, 

References & Publications (3)

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 abstrac — View Citation

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/ — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival	Survival until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with International normalized ratio (INR) > 1.5)	until day 28 from initial diagnosis of acute liver failure
Secondary	Liver transplantation	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	High urgency (HU) listing for liver transplantation	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)	until day 28 from initial diagnosis of acute liver failure
Secondary	Acute kidney injury (AKI) and max. grade of AKI (I-III)	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)	until day 28 from initial diagnosis of acute liver failure
Secondary	Renal Replacement Therapy (RRT)	Initiated renal replacement therapy 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 (encephalopathy of any grade and coagulopathy with INR > 1.5)
Secondary	Vasopressor therapy	Initiated vasopressor therapy 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 (encephalopathy of any grade and coagulopathy with INR > 1.5)
Secondary	Invasive ventilation	Initiated invasive ventilation 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 (encephalopathy of any grade and coagulopathy with INR > 1.5)
Secondary	Maximum grade of hepatic encephalopathy (HE)	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)	until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5)