| CTRI Number |
CTRI/2024/06/068527 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the effect of rinsing of new liver graft during the liver transplantaion. |
|
Scientific Title of Study
|
Graft
Rinse prior to reperfusion In LDLT, an RCT : GRIT Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudhindran S |
| Designation |
Clinical Professor and Chief Transplant Surgeon |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Room 4. Department of Gastrointestinal Surgery and Solid Organ
Transplantation
Ponekkara
Ernakulam
KERALA
682041
India |
| Phone |
9388623851 |
| Fax |
|
| Email |
sudhisalini@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudhindran S |
| Designation |
Clinical Professor and Chief Transplant Surgeon |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Room 4. Department of Gastrointestinal Surgery and Solid Organ
Transplantation
Ponekkara
Ernakulam
KERALA
682041
India |
| Phone |
9388623851 |
| Fax |
|
| Email |
sudhisalini@icloud.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhindran S |
| Designation |
Clinical Professor and Chief Transplant Surgeon |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Room 4. Department of Gastrointestinal Surgery and Solid Organ
Transplantation
Ponekkara
Ernakulam
KERALA
682041
India |
| Phone |
9388623851 |
| Fax |
|
| Email |
sudhisalini@icloud.com |
|
|
Source of Monetary or Material Support
|
| Gastro-Intestinal Surgery department, Amrita Hospital, Ponekkara P.O, Kochi, Kerala , India -682041 |
|
|
Primary Sponsor
|
| Name |
Amrita Vishwa Vidyapeetham |
| Address |
Amrita Institute of Medical sciences & Research Centre, Ponekkara P.O,Kochi, Kerala, India-682041 |
| 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 |
| DrSudhindran S |
Amrita Institute of Medical Sciences and Research Centre |
Room no.4 Department of GI surgeryAmrita Hospital, Amrita Nagar
Ponekkara
Ernakulam
KERALA |
9388623851
sudhisalini@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional ethics Committee, Amrita Institute of Medical Sciences & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Heta Starch 500 ml |
The right hepatic vein (RHV)
anastomosis will be completed (apart from the last knot)
using continuous Proline 5/0 sutures. After completion of
the portal vein (PV) anastomosis and before tying the
continuous vascufil 6/0 sutures used, the donor portal vein
will be irrigated with Solution (hetastarch 500ml pressure
(gravity). |
| Comparator Agent |
Retrograde filling(blood) |
The right hepatic vein (RHV) anastomosis
will be completed using continuous Pro- line 5/0 sutures.
After completion of the portal vein (PV) anastomosis and
before tying the continuous vascufil 6/0 sutures, RHV
clamp will be released till blood starts leaking out through
portal vein anastomosis (retrograde filling) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients undergoing live donor liver transplantation |
|
| ExclusionCriteria |
| Details |
Patient refusing to consent
Pediatric Transplants
Patients refusing to consent trial |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
incidence of postreperfusion syndrome between
control group and intervention group |
at 5 minutes post-reperfusion, |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
lengths of intensive
care stay & hospital stay, Early allograft Dysfunction,
Primary Non function of the Graft, early postop- erative
complications , & patient survival. |
in 30 days;
and 3 month -survival assessment
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study is to compare the incidence of postreperfusion syndrome between the control group (graft rinse with retrograde filling) and the intervention group (graft rinse with HETA starch solution) during liver transplantation to reduce the post-perfusion syndrome and improve post-operative outcomes. |