CytoSorb® in Patients With Acute on Chronic Liver Failure

Study Overview
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Brief Summary
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The objective of this study is to assess the safety and performance of the CytoSorb® therapy in patients with Acute on Chronic Liver Failure (ACLF) grade ≥ 2 due to a severe alcohol induced hepatitis (Maddrey DF > 32) and a severe inflammatory response.

Official Title
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A Prospective, Multi-Centre, Propensity Score Based Matched Pair Controlled, Study of Standard Medical Care Plus CytoSorb® 300 mL Device Compared to Standard Medical Care Alone in Patients With Acute on Chronic Liver Failure Due to Severe Alcoholic Hepatitis in Combination With Systemic Hyperinflammation and Acute on Chronic Liver Failure Score ≥2

Conditions
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Acute on Chronic Liver Failure, Alcoholic Hepatitis

Intervention / Treatment
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* Device: CytoSorb® treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 Signed Informed Consent Form (ICF) Total bilirubin ≥ 8 mg/dL Acute Alcoholic Hepatitis diagnosed by EtOH consumption within 6 weeks of onset of symptoms, exclusion of other causes for jaundice and liver biopsy or at least 2 out of the following symptoms: Hepatomegaly AST > ALT Elevated WBC Ascites Maddrey DF > 32 Systemic inflammation as defined by 2 fulfilled criteria out of: leucocytosis body temperature > 38°C tachycardia > 90 bpm tachypnoeia > 20 breaths/min ACLF grade ≥2 Creatinine >2 mg/dl and increase >1.5 mg/dl despite standard of care Exclusion Criteria: Platelets < 40,000/mm3 INR > 3.5 MELD Score > 35 AST > 500 IU/l Bilirubin reduction > 20% in prior 72 hours (early responders to conventional Standard of Care (SOC)) Uncontrolled infection, bleeding or hemodynamic instability Small liver size (diagnosed by imaging, ultrasound/CT) Chronic dialysis Contraindications for CytoSorb® according to Instructions for Use ACLF grade <2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CytoSorb group<br> | Device: CytoSorb® treatment<br>* Patients with Acute on Chronic Liver Failure (ACLF) due to Severe Alcoholic Hepatitis in combination with systemic inflammation and ACLF grade ≥2 will be enrolled in this study. Every patient that is screened, fulfills the inclusion/exclusion criteria, and consents to the study, will be allowed to enter the study. Patients will receive Standard of Care treatment for alcoholic hepatitis plus treatment with the CytoSorb® 300 mL device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in each group with Acute on Chronic Liver Failure (ACLF) grade <2 | To evaluate effectiveness of the CytoSorb® treatment compared to control group by comparing the proportion of patients in each group with ACLF grade <2 at the end of Day 7 after CytoSorb® therapy start (assessed by https://www.efclif.com/scientific-activity/score-calculators/clif-c-aclf). | 7 Days | 
| Safety of CytoSorb treatment | To evaluate if CytoSorb® treatment plus Standard Medical Care (SMC) compared to SMC alone is safe and tolerable as assessed by the incidence of SA(D)Es, ADEs, DDs, SADEs, and USADEs. SAE - Severe Adverse Effect; ADE - Adverse Device Effect; SADE - Severe Adverse Device Effect; DD - Device Deficiencies; USADE - Unexpected Serious Adverse Device Effect | 30 Days |