| CTRI Number |
CTRI/2025/07/090192 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Preoperative factors
and usage of Blood products in patients
undergoing Cardiac Surgery. |
|
Scientific Title of Study
|
To evaluate relationship between preoperative patient factors
and usage of Allogeneic Blood and Blood products in Adult patients
undergoing Cardiac Surgery- A prospective observational 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 |
Sanjeeta Umbarkar |
| Designation |
Professor and Head |
| Affiliation |
Seth GSMC and KEM Hospital |
| Address |
Department of Cardiac anaesthesia
Seth GSMC and KEM Hospital
Mumbai,400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9323273435 |
| Fax |
|
| Email |
sanjeetaumbarkar@kem.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sk Asim Ali |
| Designation |
Senior Resident |
| Affiliation |
Seth GSMC and KEM Hospital |
| Address |
Department of Cardiac anaesthesia
Seth GSMC and KEM Hospital
Mumbai,400012
UG/PG Hostel,
KEM Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9438278255 |
| Fax |
|
| Email |
dr.asim5241@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjeeta Umbarkar |
| Designation |
Professor and Head |
| Affiliation |
Seth GSMC and KEM Hospital |
| Address |
Department of Cardiac anaesthesia
Seth GSMC and KEM Hospital
Mumbai,400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9323273435 |
| Fax |
|
| Email |
sanjeetaumbarkar@kem.edu |
|
|
Source of Monetary or Material Support
|
| Seth GS Medical College & KEM Hospital,
Parel, Mumbai-400012, India |
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College & KEM Hospital. |
| Address |
Parel, Mumbai 400012 |
| Type of Sponsor |
Government medical college |
|
|
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 Sanjeeta Umbarkar |
Seth GS Medical College & KEM Hospital |
Cardiovascular and Thoracic Anesthesia Dept, Ground floor, Room no 305, CVTA Building, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9323273435
sanjeetaumbarkar@kem.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee-III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients of both sexes
All adult patients who undergo elective open-heart surgery
Age between18-60yrs |
|
| ExclusionCriteria |
| Details |
Emergency procedures requiring Cardiac surgery.
Redo cardiac surgery.
Transplantations of heart, lung, or heart and lung.
Pre-existing Coagulopathy, hemoglobinopathies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare perioperative blood and blood product requirements using thromboelastometry-based transfusion algorithms Vs decisions based on the clinical status. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study any post operative transfusion & non-transfusion related secondary complications following Cardiac surgery. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
25/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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 will be
conducted to estimate the requirement of Allogeneic Blood and Blood products
usage in adult patients undergoing Cardiac surgery, to determine the
association between Allogeneic Blood and blood products usage, preoperative anaemia,
haematocrit, Body Mass Index and Red cell mass, also to study any transfusion
and non-transfusion related secondary outcomes following Cardiac
surgery. Thromboelastography (TEG) machine which is the point of care
viscoelastic testing will be used for assessment of coagulation and to guide
administration of blood products. Number of intraoperative and
postoperative allogenic blood and blood products usages will be noted. Duration
of cardiopulmonary bypass time will also be noted. Any post operative complication
like prolonged mechanical lung ventilation, acute renal
failure, renal failure requiring dialysis, surgical site infection,
operative mortality and re exploration for bleeding will be noted.
|