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CTRI Number  CTRI/2026/03/106418 [Registered on: 17/03/2026] Trial Registered Prospectively
Last Modified On: 14/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   How Safe and Possible Are Living Donor Liver Transplants for People with Acute-on-Chronic Liver Failure? 
Scientific Title of Study   Clinical Feasibility of Living Donor Liver Transplantation in Patients with Acute-on-Chronic Liver Failure: An International Multicenter Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Subhash Gupta 
Designation  Consultant 
Affiliation  Max Super Specialty Hospital 
Address  Room- CLBS office, firth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area, Saket, New Delhi, Delhi 110017

South
DELHI
110017
India 
Phone  9811075683  
Fax    
Email  drSubhash.Gupta@maxhealthcare.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Peush Sahni 
Designation  Consultant 
Affiliation  Max Super Specialty Hospital 
Address  Room- CLBS office, firth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area, Saket, New Delhi, Delhi 110017

South
DELHI
110017
India 
Phone  9999646488  
Fax    
Email  peush.sahni@maxhealthcare.com  
 
Details of Contact Person
Public Query
 
Name  Dr Peush Sahni 
Designation  Consultant 
Affiliation  Max Super Specialty Hospital 
Address  Room- CLBS office, firth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area, Saket, New Delhi, Delhi 110017

South
DELHI
110017
India 
Phone  9999646488  
Fax    
Email  peush.sahni@maxhealthcare.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  KOREA UNIVERSITY COLLEGE OF MEDICINE  
Address  Room no-(02841)73, Goryeodae-ro, Seongbuk-gu, Seoul Republic of Korea 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sadhana Shankar  Dr. Rela Institute and Medical Centre  HPB surgery and Liver transplant department, DR. RELA INSTITUTE & MEDICAL CENTER, 7, CLC Works Rd, Nagappa Nagar, Chromepet, Chennai, Tamil Nadu 600044
Chennai
TAMIL NADU 
9940291975

sadhushankar@gmail.com 
Dr Subhash Gupta  Max Super Specialty Hospital  Room – CLBS Office, fifth floor, West Block, Max Super Speciality Hospital, 1 Press Enclave Marg, Saket Institutional Area, Saket, New Delhi, Delhi 110017
South
DELHI 
9811075683

drSubhash.Gupta@maxhealthcare.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Dr Rela Institute and Medical Center  Approved 
Max Healthcare Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K721||Chronic hepatic failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ACLF patients who underwent LDLT between 2013 and 2023
Definition of ACLF: A clinical syndrome characterized by acute decompensation in patients with chronic liver disease (typically cirrhosis), accompanied by failure of one or more major organ systems 
 
ExclusionCriteria 
Details  Patients with fulminant hepatic failure or acute liver failure without underlying chronic liver disease
Patients lost to follow-up within 1 year after LDLT
Patients with incomplete or insufficient medical records, making data analysis impossible
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Short-term and long-term clinical outcomes of ACLF patients undergoing LDLT and assess its clinical efficacy.
 
Research Planning & IRB Approval: 2 months
Data Collection & Analysis: 9 months
Results Reporting & Manuscript Writing: 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Risk factors identified for futility (defined as death within 3 months post-transplant or in-hospital mortality) in ACLF patients receiving LDLT and to develop predictive models for transplant outcomes.  Research Planning & IRB Approval: 2 months
Data Collection & Analysis: 9 months
Results Reporting & Manuscript Writing: 3 months
 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   N/A 
Date of First Enrollment (India)   04/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  04/04/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

This is an international multicenter retrospective study evaluating the clinical feasibility and outcomes of living donor liver transplantation (LDLT) in patients with acute-on-chronic liver failure (ACLF). The study will analyze medical records of ACLF patients who underwent LDLT between 2013 and 2023 across multiple participating institutions, including Max Super Specialty Hospital, Saket. The primary objective is to assess short-term and long-term clinical outcomes, including graft and patient survival rates at 90 days, 1 year, and 3 years post-transplantation. Secondary objectives include identifying risk factors for futility (death within 3 months or in-hospital mortality) and developing predictive models for transplant outcomes. Data will be classified according to ACLF severity (Grade 1, 2, 3) using EASL-CLIF criteria, and statistical analysis will be performed to compare outcomes and validate predictive models. The study poses no direct risk to patients as it involves retrospective analysis of anonymized medical records, ensuring confidentiality and compliance with ethical standards. The findings will contribute to evidence-based guidelines for LDLT in ACLF patients and improve personalized prognosis assessment and survival rates.


 
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