CytoSorb® in Patients With Acute on Chronic Liver Failure (HepOnFire)

CytoSorbents

Status: Withdrawn

Conditions: Acute on Chronic Liver Failure; Alcoholic Hepatitis

Treatments: Device: CytoSorb® treatment

Study type: Observational

Funder types: Industry

Identifiers

NCT05131230

L02HOF

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

CytoSorb group

Treatment:

Device: CytoSorb® treatment