Plasma Exchange in Acute on Chronic Liver Failure

• Status: Unknown status
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Acute on chronic liver failure (ACLF) is a distinct syndrome in patients with chronic liver disease with rapid clinical deterioration and has high short term mortality within one month.Despite aggressive clinical care, only half of the patients could survive an episode of ACLF. The investigators hypothesized that the early treatment with therapeutic plasma exchange with plasma and albumin in ACLF patients might improve overall survival in carefully selected patients by removing cytokines, chemokines and toxic substances.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asian Institute of Gastroenterology, India

Criteria

Inclusion Criteria:

• Patients diagnosed with ACLF as per APASL criteria with AARC score of ≥8

Exclusion Criteria:

1. Uncontrolled sepsis

2. Septic shock requiring inotropes despite fluid resuscitation

3. Active or recent bleeding (unless controlled for >48 hours).

4. Severe thrombocytopenia (≤20×10^9/L)

5. Acute kidney injury with Creatinine > 2 or the need of RRT

6. Respiratory failure (Severe ARDS)

7. Chronic kidney disease

8. Hepatocellular carcinoma outside Milan criteria (1 nodule ≤5 cm or 3 nodules ≤3 cm)

9. HIV infection

10. Pregnancy