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Effectiveness of plasma exchange (biological) in liver disease

A Randomized controlled trial to study the efficacy and safety of plasma exchange compared to standard medical therapy in patients with severe drug induced liver injury with or without underlying chronic liver disease.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020248
Enrollment
30
Registered
2019-07-18
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: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: High Volume Plasma Exchange with SMT: PLASMA EXCHANGE is therapeutic procedure in which blood of the patient is passed through a medical device which separates plasma from other compo

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Grade IV DILI With T.B > 15 2) DILI Manifesting as ACLF (Acute on chronic Liver failure) /ALF (Acute Liver Failure) with no transplant option

Exclusion criteria

Exclusion criteria: 1) Evidence of active infection 2) Refusal of consent or assent 3) Patients with clinical suspicion of irreversible brain injury 4) Pregnancy 5) HCC (Hepatocellular Carcinoma) or any other malignancy 6) Kidney failure 7) Portal vein thrombosis 8) Upper GastroIntestinal bleed 9) Transplant

Design outcomes

Primary

MeasureTime frame
Transplant free survival in both groupTimepoint: Day 28—

Secondary

MeasureTime frame
Development of organ dysfunction or failure in both groupTimepoint: Day 7,15 and 28—

Countries

India

Contacts

Public ContactDr Satyam Sinha

Institute of Liver and Biliary Sciences

shivsarin@gmail.com01146300000

Outcome results

None listed

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