CytoSorb® in Patients With Acute on Chronic Liver Failure

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

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.

Inclusion Criteria:

1. Age≥18

2. Signed Informed Consent Form (ICF)

3. Total bilirubin ≥ 8 mg/dL

4. 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

5. Maddrey DF > 32

6. Systemic inflammation as defined by 2 fulfilled criteria out of:

   • leucocytosis
   • body temperature > 38°C
   • tachycardia > 90 bpm
   • tachypnoeia > 20 breaths/min

7. ACLF grade ≥2

8. Creatinine >2 mg/dl and increase >1.5 mg/dl despite standard of care

Exclusion Criteria:

1. Platelets < 40,000/mm3
2. INR > 3.5
3. MELD Score > 35
4. AST > 500 IU/l
5. Bilirubin reduction > 20% in prior 72 hours (early responders to conventional Standard of Care (SOC))
6. Uncontrolled infection, bleeding or hemodynamic instability
7. Small liver size (diagnosed by imaging, ultrasound/CT)
8. Chronic dialysis
9. Contraindications for CytoSorb® according to Instructions for Use
10. ACLF grade <2