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Benefits of Low volume vs standard volume PLEX in Acute Liver Failure

Comparing the efficacy of low volume vs standard volume plasma exchange in patients with Acute Liver Failure - A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084781
Enrollment
42
Registered
2025-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: B150- Hepatitis A with hepatic coma Health Condition 2: B162- Acute hepatitis B without delta-agent with hepatic coma Health Condition 3: B159- Hepatitis A without hepatic coma Health Condition 4: B169- Acute hepatitis B without delta-agent and without hepatic coma Health Condition 5: B178- Other specified acute viral hepatitis Health Condition 6: B179- Acute viral hepatitis, unspecified Health Condition 7: D899- Disorder involving the immune mechanism, unspecified Health Con

Interventions

Intervention1: Low Volume Plasma Exchange in patients with Acute Liver Failure: Low Volume Plasma Exchange in patients with Acute Liver Failure - Patients allocated randomly in this arm. Total 21 case

Sponsors

Post Graduate Institute of Medical Education and Research Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with acute liver failure as per EASL/INASL/AASLD criteria. No evidence of active infection. Willing to give informed consent. Those who are not enrolled in any other study. Patients who are not intended for liver transplantation.

Exclusion criteria

Exclusion criteria: Pregnancy. Microbiological or radiological evidence of infection. Known allergy to plasma, Protamine or Heparin. Severe systemic illness like HIV. Active hemorrhage. Liver, Kidney or any other transplant recipients will be excluded. Severe pre existing cardiopulmonary disease. Coexisting HCC or any other malignancy. Death within 24 hours of presentation.

Design outcomes

Primary

MeasureTime frame
To assess efficacy of plasma exchange in terms of mortality on day 30.Timepoint: To assess efficacy of plasma exchange in terms of mortality on day 30.

Secondary

MeasureTime frame
Improvement in ALFED score, SOFA score, Clinical Prognostic index, KCH criteria to be assessed on pre procedure and on day 1,3,5,7 post procedure. Hematological and biochemical parameters will be assessed.Timepoint: On day 0(pre procedure), post procedure day 1,3,5,7

Countries

India

Contacts

Public ContactDr Divjot Singh Lamba

Post Graduate Institute of Medical Education and Research

div834@gmail.com9815464100

Outcome results

None listed

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