Acute Liver FailureAmanita-PexNCT06187220
Plasma Exchange for Amanita Toxin-induced Acute Liver Failure
An observational study of Acute Liver Failure, run by Hannover Medical School at 6 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Acute Liver Failure
- What is being tested?
- Therapeutic Plasma Exchange (PEX)
- Type of treatment
- Medical device
- How many people
- 111 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 1 Jan 2024to 10 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with Amanita toxin related acute liver failure, both adult and pediatric
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Germany2 sites
University Hospital Aachen (RWTH)
Aachen
Hannover Medical School
Hanover
About this study
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
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.
Read the 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
- Being tested
- Therapeutic Plasma Exchange (PEX)
- Keywords
- Liver Failure, Amanita Toxin, Plasmapheresis, Liver Transplantation
- Medical subject headings
- Liver Failure, Acute, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Plasma Exchange (PEX)Device
Therapeutic plasma exchange with treatment sessions >=1 replacing varying fractions of patient´s whole plasma with healthy donor plasma
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Plasma Exchange (PEX) | Patients receiving in addition to Standard Medical Therapy (SMT) at least one treatment with Therapeutic Plasma Exchange (PEX) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: until day 28 from initial diagnosis of acute liver failure
Secondary outcomes (8)
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)
Measured: until day 28 from initial diagnosis of acute liver failure
Liver transplantation
Liver transplantation until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5)
Measured: until day 28 from initial diagnosis of acute liver failure
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)
Measured: until day 28 from initial diagnosis of acute liver failure
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)
Measured: until day 28 from initial diagnosis of acute liver failure
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)
Measured: until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5)
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)
Measured: until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5)
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)
Measured: 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)
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)
Measured: until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Jan 2024
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stahl, Klaus Dr., Hannover Medical School
- Investigators
- Klaus Stahl, MD, Principal investigator, Hannover Medical School, Hannover GermanyRichard Taubert, MD, Principal investigator, Hannover Medical School, Hannover Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187220
- Sponsor's protocol ID
- Amanita-Pex
- Acronym
- Amanita-Pex
- Status last verified
- Mar 2025
- First submitted
- 16 Dec 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan to share on reasonable request
Publications
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.
PubMed 31348553Stahl 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.
PubMed 37178148Stahl 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.
PubMed 32583446
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06187220
- Acronym / sponsor ID
- Amanita-Pex / Amanita-Pex
- Conditions
- Acute Liver Failure
- Keywords
- Liver Failure, Amanita Toxin, Plasmapheresis, Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Plasma Exchange (PEX) | – | Device: Therapeutic Plasma Exchange (PEX)Patients receiving in addition to Standard Medical Therapy (SMT) at least one treatment with 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. |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with Amanita toxin related acute liver failure, both adult and pediatric
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Acute liver failure of other reason than Amanita Toxin
- Amanita Toxin associated Hepatitis or severe hepatitis without fulfilling the criteria of acute liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Plasma Exchange (PEX)Therapeutic plasma exchange with treatment sessions >=1 replacing varying fractions of patient´s whole plasma with healthy donor plasma | Device | Therapeutic Plasma Exchange (PEX) |
Primary outcome
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)
8 secondary outcomes
Overall Survival
Time frame: until day 28 from initial diagnosis of acute liver failure
Liver transplantation
Time frame: until day 28 from initial diagnosis of acute liver failure
High urgency (HU) listing for liver transplantation
Time frame: until day 28 from initial diagnosis of acute liver failure
Acute kidney injury (AKI) and max. grade of AKI (I-III)
Time frame: until day 28 from initial diagnosis of acute liver failure
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)
Vasopressor therapy
Time frame: until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5)
Invasive ventilation
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)
Time frame: until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Results publication: PubMed 31348553Stahl 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.
- Results publication: PubMed 37178148Stahl 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.
- Results publication: PubMed 32583446Stahl 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.
- Individual participant dataSharing planned: Undecided. Plan to share on reasonable request
Related trials for Acute Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Stahl, MD principal investigator
Hannover Medical School, Hannover Germany
Richard Taubert, MD principal investigator
Hannover Medical School, Hannover Germany
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Liver Failure, run by Hannover Medical School at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Italy, Mexico, Portugal, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Transplant free Survival (time frame: until day 28 from initial diagnosis of acute liver failure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06187220, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.