Use of plasma exchange in patients with alcoholic liver failure

Efficacy and tolerability of plasma exchange in patients with alcohol related acute on chronic liver failure-a pilot study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018349

Enrollment

Registered

2019-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K704- Alcoholic hepatic failure

Interventions

Intervention1: Plasma Exchange Procedure with Standard Medical Treatment: Plasma exchange shall be performed at the bedside on the enrolled patients at liver HDU (Department of Hepatology) on alternat

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than 18 years 2. First episode of de-compensation with APASL ACLF Research Consortium (AARC)- ACLF grade I or II (AARC score 3. Cause of ACLF being alcohol related liver disease 4. No evidence of active infection 5. Willing to give informed consent for the procedure(In patients who are incompetent to consent,consent shall be taken from the surrogate)

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Causes of ACLF other than alcohol 3. Co-existing HCC or extra-hepatic malignancy 4. Microbiological or radiological evidence of active infection 5. Active hemorrhage 6. Extra-hepatic multi-organ failure (>=3 organ failures) 7. APASL-AARC score >10 8. Known allergy to Plasma, Protamine or Heparin. 9. Mechanically ventilated patients 10. Severe preexisting cardiopulmonary disease 11. Requiring inotropic support 12. Renal failure requiring dialysis 13. Severe systemic illness like HIV 14. Post liver transplant patients 15. Death within 24 hours of presentation

Design outcomes

Primary

Measure	Time frame
1.Change in following Clinical Severity Scores a) Maddreyâ??s discriminant function score (MDF) for alcoholic hepatitis b) Model for end-stage liver disease(MELD score) and Child-Turcotte-Pugh(CTP)for alcoholic cirrhosis c) AARC score for ACLF d) SOF-C score(Simple Organ Failure count) 2. Clinical improvement based on LFT parameters 3. Mortality on Day 30 and Day 90 4. Duration of Hospital stay Timepoint: Baseline, Day 10, Day 30 and Day 90	—

Measure

Time frame

1.Change in following Clinical Severity Scores a) Maddreyâ??s discriminant function score (MDF) for alcoholic hepatitis b) Model for end-stage liver disease(MELD score) and Child-Turcotte-Pugh(CTP)for alcoholic cirrhosis c) AARC score for ACLF d) SOF-C score(Simple Organ Failure count) 2. Clinical improvement based on LFT parameters 3. Mortality on Day 30 and Day 90 4. Duration of Hospital stay Timepoint: Baseline, Day 10, Day 30 and Day 90

—

Secondary

Measure	Time frame
1. Cytokine assay: a)IL-6& 10levels (Pre & Post plasma exchange therapy) b)TNF-Î±level (Pre & Post plasma exchange therapy) 2. Adverse events related to Plasma exchange (Tolerability) Timepoint: Baseline, Day 10, Day 30 and Day 90	—

Countries

India

Contacts

Public ContactSHARANYA RAMAKRISHNAN

Postgraduate Institute of Medical Education and Research, CHANDIGARH

drhansrekha@gmail.com

Outcome results

None listed

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