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Clinical observation of new artificial liver CABA system (BS330+CA280) in the treatment of end-stage liver disease with inflammation

Clinical observation of new artificial liver CABA system (BS330+CA280) in the treatment of end-stage liver disease with inflammation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069285
Enrollment
Unknown
Registered
2023-03-12
Start date
2023-03-12
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End stage liver disease with inflammatory status

Interventions

CABA group:(BS330+CA280) combined with PE treatment
Control group:PP (BS330) combined with PE treatment

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 70 years. 2. Patients with end-stage liver disease, including Child-Pugh B-C patients with acute decompensation of cirrhosis, chronic liver failure, and chronic acute liver failure; (1) Acute decompensation of cirrhosis: 1) ALB 120 µmol/L; 3) ALT> 1 x ULN and/or AST> 1 x ULN; 4) PTA = 1.5; 5) Jaundice >171.1umol/L; (3) Chronic and acute liver failure: 1) Chronic liver disease is based on: chronic hepatitis or decompensated cirrhosis; 2) Onset time: = 1.5; 5) Jaundice: TBIL >= 171µmol/L or daily increase >=17.1µmol/L. 3. Inflammatory state: Any 2 of the following 4 items can be satisfied: (1) PCT>=0.50 µg/L; (2) CRP>=40 mg/L; (3) IL-6 > 5xULN; (4) IL-8 > 5xULN. 4. Understand and voluntarily sign the informed consent form approved by the Ethics Committee.

Exclusion criteria

Exclusion criteria: 1. Patients with liver malignant tumor and other tumors; 2. Patients with HIV infection or other immunodeficiency diseases; 3. Pregnant or lactating patients; 4. Patients with non-stable infarction caused by autoimmune diseases, cardiovascular and cerebrovascular accidents, organ transplantation history, and other organ dysfunction or failure; 5. Patients with other serious complications (such as active bleeding, diffuse intravascular coagulation); 6. Unable to return to the hospital for regular visits and follow-up according to the study plan; 7. Other conditions deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
Survival rate without liver transplantation (28 days and 90 days);

Secondary

MeasureTime frame
Efficient after treatment;Disease progression;

Countries

China

Contacts

Public ContactNing Qin

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

qning@vip.sina.com+86 13971521450

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026