| CTRI Number |
CTRI/2024/02/062266 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of the ability of a test measuring the clotting capacity of the blood to predict need of multiple transfusions during liver transplant surgeries |
|
Scientific Title of Study
|
Pre-operative Rotational Thromboelastometry to predict massive transfusion in liver transplant surgeries: a prospective 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 |
Dr Sharika Sriramanan |
| Designation |
Fellow in Liver Transplant Anaesthesia and Critical Care |
| Affiliation |
Dr Rela Institute and Medical Centre |
| Address |
Department of Liver Transplant Anaesthesia and Critical Care, Third Floor, Dr Rela Institute and Medical Centre, No 7, CLC Works Road, Chromepet, Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
7760413236 |
| Fax |
|
| Email |
sharika.sriramanan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amal Francis Sam |
| Designation |
Consultant |
| Affiliation |
Dr Rela Institute and Medical Centre |
| Address |
Department of Liver Transplant Anaesthesia and Critical Care, Third Floor, Dr Rela Institute and Medical Centre, Chromepet, Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
8968163281 |
| Fax |
|
| Email |
amalfsam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amal Francis Sam |
| Designation |
Consultant |
| Affiliation |
Dr Rela Institute and Medical Centre |
| Address |
Department of Liver Transplant Anaesthesia and Critical Care, Third Floor, Dr Rela Institute and Medical Centre, Chromepet, Chennai
TAMIL NADU
600044
India |
| Phone |
8968163281 |
| Fax |
|
| Email |
amalfsam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rela Institute and Medical Centre |
|
|
Primary Sponsor
|
| Name |
Dr Rela Institute and Medical Centre |
| Address |
No 7, CLC Works Road, Chromepet, Chennai |
| 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 |
| Akila Rajakumar |
Dr Rela Institute and Medical Centre |
Department of Liver Anaesthesia and Critical Care, Third Floor, Dr Rela Institute and Medical Centre, NO 7, CLC Works Road, Chromepet, Chennai
Chennai
TAMIL NADU |
9840136295
drakila.rajakumar@gmail.com |
| Dr Sharika |
Dr Rela Institute and Medical Centre |
Department of Liver Anaesthesia and Critical Care, Third floor, Dr Rela Institute and Medical Centre, No 7, CLC Works Road, Chromepet, Chennai
Chennai
TAMIL NADU |
7760413236
sharika.sriramanan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rela Institute and Medical Centre, Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K70-K77||Diseases 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 |
99.00 Year(s) |
| Gender |
Both |
| Details |
To assess whether pre-operative maximum clot firmness value of the ROTEM graph can predict incidence of massive transfusion in patients undergoing liver transplant surgeries. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patients undergoing combined liver kidney transplants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A deranged maximum clot firmness value will predict the incidence of massive blood transfusion in patients undergoing liver transplant surgery. |
Pre-operative day
Post-operative day 0 or day of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Association of deranged MCF value on ROTEM with early allograft dysfunction
2. Association of deranged MCF on ROTEM with incidence of AKI
3. Association of deranged MCF on ROTEM with increased mortality
4. Association of deranged MCF on ROTEM with sepsis |
Pre-operative day
Post-operative day 1 through Post-operative day 7 |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
30/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This is a prospective, case control study designed with 108 patients, of male and female genders, to investigate whether the maximum clot firmness value of the pre-operative ROTEM graph can be used to predict the incidence of massive transfusion in patients undergoing liver transplant surgeries. The rotational thromboelastometry or ROTEM is a laboratory visco-elastic test used to asses the clotting functions of the blood sample. Maximum clot firmness is one of the values derived from this graph and will be used in this study. The ROTEM test will be done on the pre-operative day. The incidence of massive transfusion in the surgery will be followed up. Other information regarding incidence of sepsis, acute kidney injury, early graft dysfunction and mortality will be subsequently followed up in the post operative period. |