| CTRI Number |
CTRI/2025/08/092390 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study on Haemolysis strategies During Cardiopulmonary Bypass on Adult Cardiac Surgeries |
|
Scientific Title of Study
|
A Randomized Controlled Trial Between the Interventional Strategy Vs Routine Institutional Perfusion Practice of NICS on Incidence of Haemolysis During Cardiopulmonary Bypass on Adult Cardiac Surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D E Nirman Kanna |
| Designation |
Postgraduate Student |
| Affiliation |
Narayana Hrudayalaya Foundations |
| Address |
No 258/A
Department of Clinical Perfusion
Narayana Institute Of Cardiac Sciences (NICS)
Anekal Taluk
Hosur Road, Bommasandra Industrial Area
Bangalore
KARNATAKA
560099
India |
| Phone |
6382201618 |
| Fax |
|
| Email |
denirmankanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Shetty |
| Designation |
Senior Consultant Cardiac Surgeon |
| Affiliation |
Narayana Institute Of Cardiac Sciences |
| Address |
No 258/A
Department of Cardio Thoracic and Vascular Surgery
Narayana Institute Of Cardiac Sciences (NICS)
Anekal Taluk
Hosur Road Bommasandra Industrial Area
Bangalore
KARNATAKA
560099
India |
| Phone |
9880933801 |
| Fax |
|
| Email |
varun.shetty.dr@narayanahealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Shetty |
| Designation |
Senior Consultant Cardiac Surgeon |
| Affiliation |
Narayana Institute Of Cardiac Sciences |
| Address |
No 258/A
Department of Cardio Thoracic and Vascular Surgery
Narayana Institute Of Cardiac Sciences (NICS)
Anekal Taluk
Hosur Road Bommasandra Industrial Area
Bangalore
KARNATAKA
560099
India |
| Phone |
9880933801 |
| Fax |
|
| Email |
varun.shetty.dr@narayanahealth.org |
|
|
Source of Monetary or Material Support
|
| Department of Cardio-thoracic and Vascular Surgery, Department of Clinical Perfusion,
Narayana Institute Of Cardiac Sciences (NICS) No.258 A Anekal Taluk Hosur Road Bommasandra
Industrial Area, Bangalore, Karnataka-560099 |
|
|
Primary Sponsor
|
| Name |
D E Nirman Kanna |
| Address |
No 258/A
Department of Clinical Perfusion
Narayana Institute of Cardiac Sciences (NICS)
Bommasandra Industrial Area Anekal
Bangalore
Karnataka 560099 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| D E Nirman Kanna |
Narayana Institute of Cardiac Sciences |
No 258/A
Department of Clinical Perfusion
Department of Cardiothoracic and Vascular Surgery
Narayana Institute of Cardiac Sciences (NICS)
Bommasandra Industrial Area Anekal
Pin code: 560099
Bangalore
KARNATAKA |
6382201618
denirmankanna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academic Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I71||Aortic aneurysm and dissection, (2) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (3) ICD-10 Condition: I080||Rheumatic disorders of both mitraland aortic valves, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
1 Fluid drop method using IV
set
2 Vacuum Assisted Venous
Drainage Pressures more than -40mmHg and should not
exceed -80mmHg
3 Sucker range more than 0.65
LPM during the intra OP.
4 During Cardiopulmonary
Bypass, Hematocrit should be maintained above 23%
5 If central cannulation is done,
The arterial line pressure above
170mmHg
6 If peripheral
cannulation is done, the arterial pressure should be maintained above 210mmHg
7 The mean arterial pressure of the patient should be maintained above 55mmHg during the Cardiopulmonary Bypass.
|
| Intervention |
Interventional Strategy |
1 Meniscus fall method (1 inch/
min)
2 Vacuum Assisted
Venous Drainage Pressures -20mmHg to -40mmHg
3 Sucker range less than 0.65 LPM
during the intra OP
4 During
Cardiopulmonary Bypass,
Hematocrit 25% to 27%
5 If
central cannulation done, the
arterial line pressure
120-180mmHg
6 If peripheral
cannulation done, the arterial
line pressure 150-200mmHg
7 Mean Arterial Pressure of the Patient should be maintained between 65mmHg to 75mmHg during cardiopulmonary bypass
Intervention Duration will be the Cardiopulmonary bypass duration of the case (60 minutes to 240 minutes) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult Cardiac surgeries that require the use of cardiopulmonary and CPB time of more than 60 minutes of bypass |
|
| ExclusionCriteria |
| Details |
1 Patients with renal impairments
2 Patients with hemolytic disorders
3 Patients with pre-existing hemolysis
4 Patients with cyanotic heart disease
5 Cardiac surgeries with CPB duration exceeding 240 minutes
6 Cardiac surgeries using non-occlusive pumps
7 Cases requiring a return to CPB
8 Redo surgeries (especially Mechanical valve implanted cases)
9 Emergency CPB initiation
10 Patients were unwilling to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Hemolysis |
Itra Operative (60mins after CPB ON) and Post
Operative period (24hrs after CPB OFF) POD 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To delineate the risk factors that increase the
incidence of hemolysis |
Itra Operative (60mins after CPB ON) and Post
Operative period (24hrs after CPB OFF) POD 1 |
|
|
Target Sample Size
|
Total Sample Size="402"
Sample Size from India="402"
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)
|
28/08/2025 |
| 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="0"
Months="8"
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 randomized controlled trial aims to compare the effects of a newly developed interventional perfusion strategy with the existing routine institutional perfusion practice at NICS on the incidence of haemolysis during cardiopulmonary bypass (CPB) in adult cardiac surgeries. Haemolysis, a common complication associated with CPB, can lead to adverse outcomes due to the release of free hemoglobin and other intracellular contents. The study evaluates whether the interventional strategy, potentially involving optimized pump settings such as occlusion method, vacuum-assisted venous drainage pressures, and arterial line pressure of cardiopulmonary bypass, and also the patient parameters such as intraoperative hematocrit and mean arterial pressure of the patient, can significantly reduce hemolytic markers compared to standard practices. Adult patients undergoing elective cardiac surgery requiring CPB are randomly assigned to either the interventional group or the control group. Primary outcomes include the incidence of haemolysis based on biomarkers such as the serum-free hemoglobin (hemolysis index test), lactate dehydrogenase (LDH), and serum bilirubin levels. This trial seeks to establish evidence-based improvements in perfusion protocols that may enhance patient safety and outcomes during cardiac surgery. |