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Efficacy of Plasma Exchange (procedure) Severe Alcoholic Hepatitis (liver disease).

Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function- A Randomized Controlled Trial. - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064592
Enrollment
60
Registered
2024-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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: Plasma Exchange with Standard Medical Treatment: Plasma Exchange along with all patients will receive salt restricted, high protein diet (1.5 g per kg of proteins) either enterally or p

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 to 60 years 2. Severe alcoholic hepatitis with DFmore than 80 and less than 120 or MELD more than 30 3. No liver transplant option available in near future(for atleast 1 month) 4. Patient able to bear the cost of Plasma exchange by himself/herself

Exclusion criteria

Exclusion criteria: 1. Active sepsis 2. S creatinine more than 1.5mg per dl 3. Chronic kidney disease 4. Pregnancy 5. HCC or any other malignancy 6. Active Bleeding 7. Allergic to replacement fluid (FFP) in TPE 8. Severe Hypocalcemia (less than 7.6 mg per dl) 9. Failure to give consent 10. Financial issues to bear cost of Plasma exchange

Design outcomes

Primary

MeasureTime frame
Liver transplant free survival at 28 days, 90 days.Timepoint: 28 days, 90 days.

Secondary

MeasureTime frame
End of study period (90 Days)Timepoint: 90 days;Frequency of decompensation events on follow up periodTimepoint: 28 days;Mortality at 28 daysTimepoint: 28 days;Post therapy assessment in the form of clinical improvement (hepatic encephalopathy, ascites , improvement in jaundice)(both ascites and HE if present)Timepoint: 28 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