Clinical trial NCT05131230: CytoSorb® in Patients With Acute on Chronic Liver Failure
Official title: 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: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute on Chronic Liver Failure
Alcoholic Hepatitis
Lead sponsor: CytoSorbents Europe GmbH
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients meeting the eligibility requirements of the study will receive Standard of Care treatment for alcoholic hepatitis (including steroid therapy according to AASLD/EASL guidelines and extracorporeal treatments when indicated) plus treatment with the CytoSorb® 300 mL device, a hemoperfusion adsorbent CE-certified therapy for the removal of bilirubin and pro-inflammatory cytokines (CytoSorb group).

30 propensity score matched controls from a patient database will be drawn from existing US and European sources (prospectively collected databases from geographies with comparable Standard of Care). The 30 CytoSorb group patients will be compared with these database patients.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients in each group with Acute on Chronic Liver Failure (ACLF) grade <2
timeFrame: 7 Days
measure: Safety of CytoSorb treatment
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
city: Rostock
country: Germany
facility: University of Rostock
Study officials:
References: