| CTRI Number |
CTRI/2024/07/070387 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see how liver frailty index improves after liver transplantation |
|
Scientific Title of Study
|
Recovery of liver frailty Index following liver transplantation - a prospective observational 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 |
Susan Paulin |
| Designation |
Associate consultant |
| Affiliation |
Dr Rela Institute And Medical Centre |
| Address |
Department of Liver transplant anaesthesia and critical care,
3 rd floor, ICU office,
Dr. Rela Institute and medical centre,
Chennai, TN, India
CLC works road, Shankar nagar, Chrompet, Chennai -44
Kancheepuram
TAMIL NADU
600043
India |
| Phone |
919994519890 |
| Fax |
|
| Email |
susanvercetti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Susan Paulin |
| Designation |
Associate consultant |
| Affiliation |
Dr Rela Institute And Medical Centre |
| Address |
Department of Liver transplant anaesthesia and critical care,
3 rd floor, ICU office,
Dr. Rela Institute and medical centre,
Chennai, TN, India
CLC works road, Shankar nagar, Chrompet, Chennai -44
TAMIL NADU
600043
India |
| Phone |
919994519890 |
| Fax |
|
| Email |
susanvercetti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Susan Paulin |
| Designation |
Associate consultant |
| Affiliation |
Dr Rela Institute And Medical Centre |
| Address |
Department of Liver transplant anaesthesia and critical care,
3 rd floor, ICU office,
Dr. Rela Institute and medical centre,
Chennai, TN, India
CLC works road, Shankar nagar, Chrompet, Chennai -44
TAMIL NADU
600043
India |
| Phone |
919994519890 |
| Fax |
|
| Email |
susanvercetti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rela Institute and Medical centre, Chennai, Tamil Nadu, India. Pin:600044 |
|
|
Primary Sponsor
|
| Name |
Dr Rela Institute and Medical Centre |
| Address |
Shankar Nagar, Chrompet, Chennai, Tamil Nadu, India
Pin: 600044 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Susan Paulin |
Dr Rela Institute and medical centre |
Shankar Nagar, Chrompet, Chennai
Kancheepuram
TAMIL NADU |
9994519890
susanvercetti@gmail.com |
| Dr Akila Rajakumar |
Dr. Rela Institute and medical center |
Department of Liver transplant anaesthesia and critical care,
3 rd floor, ICU office,
Chennai, TN, India. Pin 600044
Kancheepuram
TAMIL NADU |
919840136295
drakila.rajakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- Dr Rela Institute and medical centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K74||Fibrosis and cirrhosis of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All post liver transplant recipients who come for follow up at Dr Rela Institute and medical centre after 1 month and within 1 year following liver transplantation |
|
| ExclusionCriteria |
| Details |
Patients not willing for participation in the trial
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate Improvement of fragility status using change in LFI scores in the first year following liver transplantation as compared to their pre transplant LFI scores. |
1 month, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate factors that contribute to delayed improvement of frailty in the first year following liver transplantation |
1 month, 1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/07/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [susanvercetti@gmail.com].
- For how long will this data be available start date provided 15-07-2024 and end date provided 31-01-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
All patients who have undergone liver transplantation in the past 1 year at our centre will be recruited for the study. Data pertaining to general demographics, MELD and LFI at transplant, post-transplant events and follow up details including hospitalizations and ICU admissions will be collected from the patients. Repeat LFI will be performed at the physiotherapy outpatient clinic. Details regarding post-transplant nutritional and physical rehabilitation if any shall be recorded. |