| CTRI Number |
CTRI/2024/01/061996 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of events related to brain function in transplant patient |
|
Scientific Title of Study
|
Neurological Complications in early postoperative period following live donor Liver Transplantation: A Retrospective Analysis. |
| 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 Swagat Pattajoshi |
| Designation |
Associate Consultant |
| Affiliation |
Medanta - The Medicity, Gurugram |
| Address |
Department of critical care medicine and anesthesia
Medanta - The Medicity
Sector 38, Gurugram,
Haryana
Gurgaon
HARYANA
122001
India |
| Phone |
9337186991 |
| Fax |
|
| Email |
pattajoshiswagat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swagat Pattajoshi |
| Designation |
Associate Consultant |
| Affiliation |
Medanta - The Medicity, Gurugram |
| Address |
Department of critical care medicine and anesthesia
Medanta - The Medicity
Sector 38, Gurugram,
Haryana
HARYANA
122001
India |
| Phone |
9337186991 |
| Fax |
|
| Email |
pattajoshiswagat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swagat Pattajoshi |
| Designation |
Associate Consultant |
| Affiliation |
Medanta - The Medicity, Gurugram |
| Address |
Department of critical care medicine and anesthesia
Medanta - The Medicity
Sector 38, Gurugram,
Haryana
HARYANA
122001
India |
| Phone |
9337186991 |
| Fax |
|
| Email |
pattajoshiswagat@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Swagat Pattajoshi |
ICU 10 Medanta, The Medicity |
Sector 38, Gurgaon, Haryana-122001
Gurgaon
HARYANA |
9337186991
pattajoshiswagat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee (MIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, (2) ICD-10 Condition: G405||Epileptic seizures related to external causes, |
|
|
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 |
Adult post LDLT patients diagnosed with any new neurological condition within 10 days post-transplant or discharge or death |
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Patients in whom preoperative neurological status could not be accessed
Patients of retransplant or dual organ transplant
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of neurological events within 10 days post-transplant or discharge or death; whichever is earlier. |
Within 10 days post-transplant or discharge or death; whichever is earlier. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association of factors with neurological events
Length of ICU stay within 10 days post-transplantation
|
Within 10 days post-transplantation
|
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
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)
|
12/02/2024 |
| 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) |
Suspended |
|
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 study is to look for neurological events, associated factors & outcomes in patients in early postoperative period (10 days, death or discharge) who had undergone live donor liver transplantation at the site from June 2010 to November 2023. Adult, Age > 18 years post LDLT patients diagnosed with any new neurological condition within 10 days post-transplant/discharge/death will be included in the study. Age <18 years, Patients in whom, preoperative neurological status could not be accessed, Patients of retransplant or dual organ transplant will be excluded. This will be a retrospective analysis to study the neurological events in adult patients who had undergone living donor liver transplantation at the site from June 2010 to November 2023. Primary outcome of the study is Incidence of neurological events within 10 days post-transplant or discharge or death; whichever is earlier. The secondary outcome of the study is association of factors with neurological events and length of ICU stay within 10 days post-transplantation. |