| CTRI Number |
CTRI/2024/05/066783 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to compare two ways of deciding when to give blood transfusions during liver transplant to recipient which tests if Thromboelastography(Test 1) or Rotational thromboelastometry (Test 2)is better and the total amount of blood transfused between two groups will be compared. |
|
Scientific Title of Study
|
Thromboelastography versus Rotational Thromboelastometry Guided Blood Transfusion in Living Donor Liver Transplantation - A Randomised Controlled Trial |
| 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 Rachana C Nair |
| Designation |
Senior Resident |
| Affiliation |
Institute Of Liver and Biliary Sciences (ILBS) |
| Address |
Room no-B4, Department Of Anesthesia
Institute Of Liver and Biliary Sciences (ILBS)
Vasantkunj, Delhi
South West
DELHI
110070
India |
| Phone |
9400465302 |
| Fax |
|
| Email |
rachanacnair89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Sindwani |
| Designation |
Associate Professor |
| Affiliation |
Institute Of Liver and Biliary Sciences (ILBS) |
| Address |
Room no-3316, Department Of Anesthesia
Institute Of Liver and Biliary Sciences (ILBS)
Vasantkunj, Delhi
South West
DELHI
110070
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Sindwani |
| Designation |
Associate Professor |
| Affiliation |
Institute Of Liver and Biliary Sciences (ILBS) |
| Address |
Room no-3316, Department Of Anesthesia
Institute Of Liver and Biliary Sciences (ILBS)
Vasantkunj, Delhi
South West
DELHI
110070
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute Of Liver and Biliary Sciences (ILBS),D-1,Vasant Kunj, New Delhi-110070 |
|
|
Primary Sponsor
|
| Name |
Institute Of Liver and Biliary Sciences (ILBS) |
| Address |
D-1, Vasant Kunj
Delhi
110070
|
| Type of Sponsor |
Other [self] |
|
|
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 Rachana C Nair |
Institute Of Liver and Biliary sciences |
Room no 1056, Department of Anaesthesiology, ,ILBS D-1, Vasant Kunj
Delhi
110070
South West
DELHI |
9400465302
rachanacnair89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Institute Of Liver and Biliary Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ROTEM Test |
ROTEM
Intraoperatively during baseline, dissection, anhepatic and post reperfusion
Postoperatively till day 3 |
| Comparator Agent |
TEG test |
Intraoperatively baseline, dissection ,anhepatic and post reperfusion
Postoperatively till day 3
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients undergoing living donor liver transplant at our institute. |
|
| ExclusionCriteria |
| Details |
1)Acute liver failure patients, Acute on chronic liver failure patients
2) Pediatric patients
3)Retransplantation in a patient previously randomized in this trial
4) Without informed consent
5) Patients with known coagulation factor deficiencies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total PRBCs transfused between two groups. |
Baseline, dissection phase, anhepatic phase, post reperfusion and postoperative day 1 ,2 and 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To compare the amount of FFP,Cryoprecipitate & platelets transfused between both groups
2.To compare the changes in coagulation during different stages of liver transplant between the two groups
3. To compare the duration of mechanical ventilation |
Baseline
Dissection phase
Anhepatic phase
Post reperfusion
Postoperative day 1, 2 & 3
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| Date of Study Completion (India) |
15/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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)
|
On the day of surgery, patient will be transferred to operation theatre. All ASA standard monitors will be attached. Institute protocol for conduct of anesthesia will be followed.Normothermia will be maintained.Patients will be randomized into TEG group and ROTEM group. Block randomization will be done. Sample size being 80, 8 blocks will be used and in each block, 10 patients will be taken and among those 10 patients, 5 patients will be allocated TEG group and 5 patients will be allocated ROTEM group Blood samples will be drawn from an existing arterial catheter. Either TEG or ROTEM will be performed as per randomised chart. All tests will be performed by designated group of anaesthesia technicianse TEG GROUP In patients belonging the TEG group, blood will be collected in 3.5-mL tubes containing 3.2% citrate for assay with the TEG 5000 Haemostatic Analyser (Haemonetics, Braintree, MA). The following TEG measurements will be recorded: R time (minutes), angle (alpha, degrees), K (kinetics), maximum amplitude (MA, mm), FF TEG, lysis 30 min after MA (LY30, %), coagulation index.
On the day of surgery, patient will be transferred to operation theatre. All ASA standard monitors will be attached. Institute protocol for conduct of anesthesia will be followed. Normothermia will be maintained. Baseline TEG and ROTEM will be performed. Patients will be randomized into TEG group and ROTEM group. Block randomization will be done. Sample size being 80, 8 blocks will be used and in each block, 10 patients will be taken and among those 10 patients, 5 patients will be allocated TEG group and 5 patients will be allocated ROTEM group Blood samples will be drawn from an existing arterial catheter. Either TEG or ROTEM will be performed as per randomised chart. All tests will be performed by designated group of anaesthesia technicianse TEG GROUP In patients belonging the TEG group, blood will be collected in 3.5-mL tubes containing 3.2% citrate for assay with the TEG 5000 Haemostatic Analyser (Haemonetics, Braintree, MA). The following TEG measurements will be recorded: R time (minutes), angle (alpha, degrees), K (kinetics), maximum amplitude (MA, mm), FF TEG, lysis 30 min after MA (LY30, %), coagulation index. ROTEM GROUP For patients undergoing ROTEM (ROTEM assay, Pentapharm GmbH, Germany), blood will be collected in 3.2% citrate tubes EXTEM, FIBTEM will be performed Thromboelastometric parameters to be analysed: (1) clotting time (CT), (2) clot formation time (CFT), (3) clot firmness after 10 minutes (A10 min), and maximum clot firmness (MCF), FIBTEM MCF,and maximum lysis at 30 minutes . TEG and ROTEM guided correction will be done as per algorithm |