| CTRI Number |
CTRI/2024/06/068281 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
01/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Observtional Study |
| Study Design |
Other |
|
Public Title of Study
|
Development of a score to know its usefulness in predicting the outcomes after liver transplantation |
|
Scientific Title of Study
|
DEVELOPMENT AND VALIDATION OF A PROGNOSTIC SCORE FOR PREDICTING OUTCOMES IN PATIENTS UNDERGOING LIVING DONOR LIVER TRANSPLANTATION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gaurav Sindwani |
| Designation |
Associate Professor, Department of Anesthesiology |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
Institute of Liver and Biliary Sciences,
Sector D1, Vasant Kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Sindwani |
| Designation |
Associate Professor, Department of Anesthesiology |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
Institute of Liver and Biliary Sciences,
Sector D1, Vasant Kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali |
| Designation |
Senior Resident, Department of Anesthesiology |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
Institute of Liver and Biliary Sciences,
Sector D1, Vasant Kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
9080916747 |
| Fax |
|
| Email |
vaishalissri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of liver and biliary sciences |
|
|
Primary Sponsor
|
| Name |
Institute of liver and biliary sciences |
| Address |
Department of Anesthesiology, Room No. 3311,3rd floor, Phase II, D-1 block,Vasant Kunj, New Delhi-110070, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Vaishali |
Institute of liver and biliary sciences |
Department of Anesthesiology, Room No. 3311,3rd floor, Phase II, D-1 block,Vasant Kunj, New Delhi-110070, India
South West
DELHI |
9080916747
vaishalissri@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K704||Alcoholic hepatic failure, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. PATIENTS WHO HAD LIVING DONOR LIVER TRANSPLANTATION
2. PATIENTS DIAGNOSED WITH CHRONIC LIVER DISEASE |
|
| ExclusionCriteria |
| Details |
1. ACUTE LIVER FAILURE
2. ACUTE ON CHRONIC LIVER FAILURE
3. HEPATOCELLULAR CARCINOMA
4. PAEDIATRIC POPULATION |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO DEVELOP AND VALIDATE THE ROLE OF NEW SCORE IN LIVER TRANSPLANT RECIPIENTS IN PREDICTING EARLY MORTALITY |
28 days and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the risk factors associated with one year mortality in patients undergoing living donor liver transplantation |
1 year |
|
|
Target Sample Size
|
Total Sample Size="514"
Sample Size from India="514"
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)
|
13/06/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Liver transplantation is a viable treatment option for patients with end stage liver disease, hepatocellular carcinoma, fulminant hepatitis. The outcome of liver transplant has been improved in later days due to advancements in surgical techniques , immunosuppression , enhanced knowledge in managing the allograft recipient . Despite the multiple options , there is no agreement on the best scoring system to predict outcomes after liver transplant.The presently used scores have poor sensitivity and specificity in predicting the outcomes after the surgery. The anaesthesia and surgical factors play a very important role in predicting the outcome of surgery. The outcome after surgery also predominantly depends upon the disease severity, patient factors. None of the previous scores have included patient factors like sarcopenia, MELD-Na and anaesthesia & surgical factors (fluid requirement including blood transfusion, inotropic support, cold ischemia time ,warm ischemia time, GRWR ) into a simple single score. So we aimed to consolidate all these factors into a new scoring system . Hence, the aim of the present study is to develop a novel scoring system to predict the outcome after the LDLT.
|