WithdrawnNot Applicable

CytoSorb® in Patients With Acute on Chronic Liver Failure

Stopped: No patients enrolled

Germany0Started 2022-03-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age≥18
✓. Signed Informed Consent Form (ICF)
✓. Total bilirubin ≥ 8 mg/dL

Exclusion criteria

✕. Maddrey DF \> 32
✕. Systemic inflammation as defined by 2 fulfilled criteria out of:
✕. ACLF grade ≥2
✕. Creatinine \>2 mg/dl and increase \>1.5 mg/dl despite standard of care
✕. Platelets \< 40,000/mm3
✕. INR \> 3.5
✕. MELD Score \> 35
✕. AST \> 500 IU/l

What they're measuring

Proportion of patients in each group with Acute on Chronic Liver Failure (ACLF) grade <2

Timeframe: 7 Days

Safety of CytoSorb treatment

Timeframe: 30 Days

Trial details

NCT IDNCT05131230

SponsorCytoSorbents Europe GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-03

View on ClinicalTrials.gov More Acute on Chronic Liver Failure trials