A study to determine if a new therapy(Plasma Exchange) can help in recovery of Acute on chronic Liver failure.

Plasma Exchange in Acute on chronic Liver Failure: A Randomized Control Trial.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039094

Enrollment

194

Registered

2022-01-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: K720- Acute and subacute hepatic failure

Interventions

Intervention1: Therapeutic Plasma Exchange: The replacement will be done by using the combination of 1/3rd albumin/Normal saline+ 2/3rd plasma (FFP) where albumin used is 5%W/V (if 20% albumin is used

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent. 2. 18 – 60 years of age 3. EASL-ACLF grade 1, 2 and 3

Exclusion criteria

Exclusion criteria: 1. Systolic blood pressure 2. Lack of informed consent 3. Coexisting severe illness e.g., coronary artery disease, malignancy etc 4. Post Liver Transplant patients 5. Pregnancy 7. Active infection- bacterial or fungal. 8. Hepatocellular carcinoma 9. Patient who dies within 48 hrs of admission

Design outcomes

Primary

Measure	Time frame
To study the effect of Plasma Exchange (PE) on 28-day mortality in patients with ACLF.Timepoint: 28 days	—

Secondary

Measure	Time frame
1) To study the effect of PE on APASAL ACLF Research Consortium (AARC) score, CLIF-C ACLF score, Acute Physiology and Chronic Health Evaluation (APACHE) II, and Systemic Inflammatory Response Syndrome (SIRS). 2) To study the effect of PE on the resolution or development of organ failures in ACLF. 3) To study the effect of plasma exchange on cytokine profile which includes pro-inflammatory cytokines (INF-A2, INF-G, IL-12, IL-15, IL-17, MCP-3, IL-6, MCP-1, MIP -1A, MIP-1B, TNF-A, TNF-B, IL-8, RNTS, IP – 10, ETXN), anti-inflammatory cytokines (IL-2, IL-4, IL-5, IL-10, IL-1RA, IL-7), growth factors (EGF, FGF-2, TGF A, G-CSF, GM-CSF, PDGF), DAMPS (HMGB1), endotoxin in ACLF. 4) To study the incidence of infections and other complications in ACLF patients undergoing plasma exchangeTimepoint: 1) 28 days 2) 28 days 3) 28 days 4) 28 days	—

Measure

Time frame

1) To study the effect of PE on APASAL ACLF Research Consortium (AARC) score, CLIF-C ACLF score, Acute Physiology and Chronic Health Evaluation (APACHE) II, and Systemic Inflammatory Response Syndrome (SIRS). 2) To study the effect of PE on the resolution or development of organ failures in ACLF. 3) To study the effect of plasma exchange on cytokine profile which includes pro-inflammatory cytokines (INF-A2, INF-G, IL-12, IL-15, IL-17, MCP-3, IL-6, MCP-1, MIP -1A, MIP-1B, TNF-A, TNF-B, IL-8, RNTS, IP – 10, ETXN), anti-inflammatory cytokines (IL-2, IL-4, IL-5, IL-10, IL-1RA, IL-7), growth factors (EGF, FGF-2, TGF A, G-CSF, GM-CSF, PDGF), DAMPS (HMGB1), endotoxin in ACLF. 4) To study the incidence of infections and other complications in ACLF patients undergoing plasma exchangeTimepoint: 1) 28 days 2) 28 days 3) 28 days 4) 28 days

—

Countries

India

Contacts

Public ContactDr Shekhar Swaroop

All India Institute of Medical Sciences

s.swaroop123456@gmail.com9113139210

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 1, 2026