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To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF).

NCT03162419 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-12-03

No results posted yet for this study

Summary

Study design-Open label randomized controlled trial

Study period-2 years

Study population-All patients of ACLF admitted to ILBS for a period of two years from Feb 2017 to Dec 2018

All the patients of ACLF will receive standard medical therapy and will be randomized within 48 hours of admission into three groups after screening for exclusion and inclusion criteria.(1:2:2) Group A-Standard Medical Therapy only Group B-Standard Medical therapy + Plasma exchange + GCSF Group C-Standard Medical Therapy + GCSF

Conditions

  • Acute-On-Chronic Liver Failure

Interventions

DRUG

Standard Medical Therapy

The patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.

BIOLOGICAL

Plasma Exchange

High volume plasma exchange sessions till a maximum of ten sessions.

BIOLOGICAL

GCSF

The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2019-04-25
Completion
2019-04-25

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03162419 on ClinicalTrials.gov