| CTRI Number |
CTRI/2022/10/046564 [Registered on: 17/10/2022] Trial Registered Prospectively |
| Last Modified On: |
01/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
During liver surgery using comparing two methods to monitor the blood clotting |
|
Scientific Title of Study
|
Prospective PeriOperative study Evaluating Routine Coagulation versus Thromboelastography for Liver resections (PORTAL 2 Trial ) |
| Trial Acronym |
PORTAL - 2 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reshma Ambulkar |
| Designation |
Professor |
| Affiliation |
Tata memorial hospital |
| Address |
2nd floor, Main building, Department of Anaesthesia Critical Care and Pain,Dr.E Borges Roaad, Parel . Mumbai, 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9821790448 |
| Fax |
|
| Email |
rambulkar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reshma Ambulkar |
| Designation |
Professor |
| Affiliation |
Tata memorial hospital |
| Address |
2nd floor, Main building, Department of Anaesthesia Critical Care and Pain,Dr.E Borges Roaad, Parel .
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9821790448 |
| Fax |
|
| Email |
rambulkar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reshma Ambulkar |
| Designation |
Professor |
| Affiliation |
Tata memorial hospital |
| Address |
2nd floor, Main building, Department of Anaesthesia Critical Care and Pain,Dr.E Borges Roaad, Parel .
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9821790448 |
| Fax |
|
| Email |
rambulkar@hotmail.com |
|
|
Source of Monetary or Material Support
|
| TMC Research Administration Council(TRAC)
2nd floor, Main building, Department of Anaesthesia Critical Care and Pain,Dr.E Borges Roaad, Parel . Mumbai, 400012 |
|
|
Primary Sponsor
|
| Name |
TRAC |
| Address |
Tata memorial hospital,
Dr.E. Borges Road , Parel
Mumbai |
| 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 |
| Reshma Ambulkar |
TATA MEMORIAL HOSPITAL |
Department of Anaesthesia Critical Care and Pain, 2nd floor, Main building,Dr.E. Borges Road , Parel , Mumbai
Mumbai
MAHARASHTRA |
9821790448
rambulkar@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
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 |
Blood investigations taken |
TEG And Complete blood count and coagulation tests are sent at five time points - Preincision, Intraoperative (based at discretion of OT anaesthetists) , Postoperative, 48 hrs, 5th postop day |
| Comparator Agent |
INR |
INR (more than 1.5) It is used to assess the risk of bleeding or the coagulation status of the patients. |
| Intervention |
Thromboelastography TEG |
TEG And Complete blood count and coagulation tests are sent at five time points - Preincision, Intraoperative (based at discretion of OT anaesthetists) , Postoperative, 48 hrs, 5th postop day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
20 patients with cirrhosis as determined by Fibroscan (Fibrosis score 4) posted for liver resection will be included in the study. |
|
| ExclusionCriteria |
| Details |
On therapeutic doses of thromboprophylaxis , Abnormal coagulation or platelets , Any known coagulation disorders , Refusal of consent , Fibrosis score ≤ F3 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary aim of our study is to study the serial changes of conventional coagulational tests and thromboelastography in cirrhotic patients undergoing major liver resection during perioperative period |
1.Preincision
2.Intraoperative (based at discretion of OT anaesthetists)
3.Postoperative
4.48 hrs post surgery
5.5th post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To record the incidence of prevention of transfusion of blood products
2. Incidence of complications
a. Bleeding
b.Deep vein thrombosis,
c.Epidural hematoma |
1POD 1, POD 2 POD 3 POD 4 POD 5
2 POD 1, POD 2 POD 3 POD 4 POD 5 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
18/10/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of our study is to study the serial changes of conventional coagulation tests and thromboelastography (both are tests for assessing the clotting status of the patient) during post operative period in patients undergoing major liver resection (more than 3 segment). Unlike traditional coagulation assays, which measure components of blood and portions of the coagulation pathway separately, TEG uses whole blood to measure functional coagulation. This allows for active involvement of the red blood cell, white blood cell, platelet and plasma components of coagulation. Bleeding and vascular thrombosis are major life threatening complications following liver surgery. Following major hepatectomty, there will be altered clotting status, do even when the routine tests are high and TEG is normal, blood transfusions can be avoided, and complications from blood transfusions can be avoided. This study will be initiated after approval from the institutional ethics committee and registration with CTRI. 20 patients with cirrhosis as determined by Fibroscan posted for liver resection other than those meeting exclusion criteria will be included in this prospective interventional study. Consent for the participation in the study will be taken from all eligible patients. Blood samples will be taken from the patient after getting admitted in hospital. The patient will be taken blood samples at five point of time 1. Preincision (after anaesthetized and before surgery), 2. During intraop (during surgery time as per ot anaesthetist), 3. Immediately after surgery, 4. At 48 hrs and 5. On day 5. Blood samples will be taken for CBC (normal blood test for hemoglobin, and cell counts), routine coagulation tests and TEG. In this study patient’s medical records will be assessed for the demographic details (age, sex, and weight etc.), clinical data (primary diagnosis and details of surgery) and the blood test reports will be recorded at various intervals as per study design |