CTRI

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CTRI Number

CTRI/2024/03/064592 [Registered on: 21/03/2024] Trial Registered Prospectively

Last Modified On:

06/06/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Biological

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

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

Scientific Title of Study

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

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
None	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Jitendra Kumar Singh
Designation	Senior Resident,Department of hepatology
Affiliation	Institute of Liver and Biliary Sciences
Address	Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi-110070. South West DELHI 110070 India
Phone
Fax
Email	jitendra2602kc@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Shasthry S M
Designation	Additional Professor, Department of Hepatology
Affiliation	Institute of Liver and Biliary Sciences
Address	Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi-110070. South West DELHI 110070 India
Phone	01146300000
Fax
Email	shasthry@gmail.com

Details of Contact Person
Public Query

Name	Dr Shasthry S M
Designation	Additional Professor, Department of Hepatology
Affiliation	Institute of Liver and Biliary Sciences
Address	Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi-110070. DELHI 110070 India
Phone	01146300000
Fax
Email	shasthry@gmail.com

Source of Monetary or Material Support

ILBS,D-1,vasant Kunj,New Delhi-110070

Primary Sponsor

Name	Institute of Liver and Biliary Sciences
Address	Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi-110070.
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Jitendra Kumar Singh	Institute of Liver and Biliary Sciences	Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi-110070. South West DELHI	01146300000 jitendra2602kc@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, ILBS	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K746\|\|Other and unspecified cirrhosis ofliver,

Intervention / Comparator Agent

Type	Name	Details
Intervention	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 parenterally in addition to thiamine and multivitamins,35 to 45 kcal per kg. Duration: 10 days
Comparator Agent	Standard Medical Treatment	All patients will receive salt restricted, high protein diet (1.5 g per kg of proteins) either enterally or parenterally in addition to thiamine and multivitamins,35 to 45 kcal per kg. Duration: 10 days

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	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

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Liver transplant free survival at 28 days, 90 days.	28 days, 90 days.

Secondary Outcome

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

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3

Date of First Enrollment (India)

01/04/2024

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Hypothesis: we hypothesise that the early treatment with therapeutic plasma exchange in alcoholic hepatitis patients might improve overall survival in carefully selected patients by removing cytokines, chemokines and toxic substances.

Aim: To compare transplant free survival between plasma exchange therapy and standard medical therapy in severe alcoholic hepatitis

Methodology:

Severe alcoholic hepatitis will be screened for the study and will be managed with SMT initially will be assessed for steroid therapy if becomes ineligible counselled for liver transplant in view of high DF and MELD ,if there is no options of Liver transplant in near future ,1 month will be given option for PLEX but it will be decided by randomisation whether he will get SMT or PLEX.He/she will also be told that PLEX is not a approved treatment and is a trial therapy and they may or may not get benefited.Patients Patients who agreed to undergo PLEX then undergo randomisation between PLEX and SMT and allocated in either group accordingly.

Control group will be administered SMT only.Case are those who get both SMT and PLEX. SMT involved empirical antibiotics as per treating physician,multivitamins,albumin. Hepatic encephalopathy (HE) will be treated with lactulose and rifaximin. Ascites with diuretics if not contraindicated because of renal insufficiency or HE. All patients will receive salt restricted, high protein diet (1.5 g/kg of proteins) either enterally/parenterally in addition to thiamine and multivitamins,35 to 45 kcal /kg .

Cases will be administered SMT with Plasma exchange session which will be done on alternate day to a maximum of 5 sessions. PLEX will be discontinued if the patients Shows sustained clinical improvement, Receive liver transplantation, Refuses further PLEX session,no improvement in clinical condition and Intolerant to PLEX procedure

Study population:

1. 1) Age - 18-60 years

2. 2) Patients with steroid ineligible (DF > 80< 120, MELD > 30) severe alcoholic hepatitis (Bili > 5 ,INR > 1.5)

Study Design: Randomised controlled study done at Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.