CytoSorb® in Patients With Acute on Chronic Liver Failure

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2023

Interventions

  • Device: CytoSorb® treatment
    • 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.

Arms, Groups and Cohorts

  • CytoSorb group

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients in each group with Acute on Chronic Liver Failure (ACLF) grade <2
    • Time Frame: 7 Days
    • 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).
  • Safety of CytoSorb treatment
    • Time Frame: 30 Days
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CytoSorbents Europe GmbH
  • Provider of Information About this Clinical Study
    • Sponsor

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