Effect of Plasmapheresis (biological procedure) in Liver Disease patients.

Efficacy of Plasmapheresis in Patients of severe Drug-Induced Liver Injury (DILI) with underlying chronic liver disease: An open labelled RCT. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079782

Enrollment

Registered

2025-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: PLEX with SMT: Frequency: High Volume Plex with minimum 3 sessions on alternate days along with Standard treatment. Route: intravenous Duration: Minimum 3 sessions Control Intervention1

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18-75 years with previously known or unknown underlying CLD 2. Diagnosis of DILI based causality of assessment by RECAM. 3. Severe DILI with bilirubin more than 12mg/dl or INR ore than 2, S.Bili more than 5 mg per dl 4. Consent to participate in the study (based on biopsy/imaging/or clinical criteria)

Exclusion criteria

Exclusion criteria: 1. Active infection 2. Contraindications to plasmapheresis (e.g., severe coagulopathy, hemodynamic instability, patients with sepsis, shock, poor PF ratio). 3. Pregnant or breastfeeding women. 4. HCC or any malignancy 5. UGI bleed, uncontrolled HE 6. Option LTx being considered 7. S. Creatinine more than 2mg/dL 8. DILI ALF 9. Alcoholic Hepatitis

Design outcomes

Primary

Measure	Time frame
Liver Transplant free survival at the end of 30 days between two groups.Timepoint: 30 days	—

Secondary

Measure	Time frame
Changes in arterial lactate levels, on lactate clearance at 0, 3, 5 daysTimepoint: 0, 3, 5 days;Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 daysTimepoint: 0, 3, 5,30 and 90 days;Reduction in von Willebrand factor levels, endothelial function, and coagulopathy at 0 and 30 day.Timepoint: 0 and 30 day.;Changes in arterial lactate levels, on lactate clearance at 0,3 daysTimepoint: 0,3 days;Changes in the inflammatory milieu, IL6, IL10, and TNF alpha at 0 and 30 dayTimepoint: 0 and 30 day;Change in liver-related decompensation events (ascites, HE, variceal bleed) at 0, 3, 5,30, and 90 days.Timepoint: 0, 3, 5,30, and 90 days;Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 days.Timepoint: 0, 3, 5,30 and 90 days.	—

Measure

Time frame

Changes in arterial lactate levels, on lactate clearance at 0, 3, 5 daysTimepoint: 0, 3, 5 days;Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 daysTimepoint: 0, 3, 5,30 and 90 days;Reduction in von Willebrand factor levels, endothelial function, and coagulopathy at 0 and 30 day.Timepoint: 0 and 30 day.;Changes in arterial lactate levels, on lactate clearance at 0,3 daysTimepoint: 0,3 days;Changes in the inflammatory milieu, IL6, IL10, and TNF alpha at 0 and 30 dayTimepoint: 0 and 30 day;Change in liver-related decompensation events (ascites, HE, variceal bleed) at 0, 3, 5,30, and 90 days.Timepoint: 0, 3, 5,30, and 90 days;Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 days.Timepoint: 0, 3, 5,30 and 90 days.

—

Countries

India

Contacts

Public ContactDr Shasthry S M

Institute of Liver and Biliary Sciences

shasthry@gmail.com01146300000

Outcome results

None listed

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