| CTRI Number |
CTRI/2024/12/078407 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2025 |
| 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
|
Incidence of Haemolysis during Cardiopulmonary Bypass on Adult Cardiac Surgeries |
|
Scientific Title of Study
|
A Pilot Randomized Controlled Trial 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 Institute of Medical Sciences |
| Address |
Department of Clinical Perfusion,
Narayana Institute Of Cardiac Sciences (NICS)
No.258 A
Anekal Taluk
Hosur Road
Bommasandra Industrial Area
Department of Clinical Perfusion, Narayana Institute Of Cardiac Sciences (NICS)
No. 258 A
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 |
Department of Cardio-Thoracic and Vascular Surgery,
Narayana Institute Of Cardiac Sciences (NICS)
No.258 A
Anekal Taluk
Hosur Road
Bommasandra Industrial Area
Department of Cardio-Thoracic and Vascular Surgery, Narayana Institute Of Cardiac Sciences (NICS)
No.258 A
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 |
Department of Cardio-Thoracic and Vascular Surgery, Narayana Institute Of Cardiac Sciences (NICS)
No.258 A
Anekal Taluk
Hosur Road
Bommasandra Industrial Area
Department of Cardio-Thoracic and Vascular Surgery, Narayana Institute Of Cardiac Sciences (NICS)
No.258 A
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 |
Narayana Hrudayalaya Institute of Medical Sciences, Bangalore. 258/A, Bommasandra Industrial Area , Anekal Taluk, Hosur Road Bangalore, Karnataka - 560099 |
| 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 |
| D E Nirman Kanna |
Narayana Institute of Cardiac Sciences |
Narayana Institute Of Cardiac Sciences 258 A
Bhommasandra
Anekal Taluk
Bommasandra Industrial Area
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: I20-I25||Ischemic heart diseases, (2) ICD-10 Condition: I71||Aortic aneurysm and dissection, |
|
|
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 than -80mmHg
3. Sucker range more than 0.65 lpm during the intra OP.
4. During Cardiopulmonary Bypass, Hematocrit 27%to 30%
5. If central cannulation done, the arterial line pressure above 170mmHg
6. If peripheral cannulation is done, the arterial line pressure 210mmHg |
| Intervention |
Interventional Group |
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 23%to 27%
5. If central cannulation done, the arterial line pressure 120-160mmHg
6. If peripheral cannulation done, the arterial line pressure 150-200mmHg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult Cardiac surgeries which require the use of cardiopulmonary bypass and CPB time more than 60mins. |
|
| 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 unwilling to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Hemolysis |
Itra Operative (60mins after CPB ON) and Post Operative period (12hrs after CPB OFF) POD 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To delineate the risk factors that increase the incidence of hemolysis |
Itra Operative (60mins after CPB ON) & Post Operative period (12hrs after CPB OFF) POD 0 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2025 |
| Date of Study Completion (India) |
11/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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)
|
BACKGROUND
The utilization of cardiopulmonary bypass (CPB) is
nearly inevitable in cardiac surgery. Yet, it can lead to complications such as
hemolysis, which is a significant factor in postoperative kidney injury and
intestinal mucosal damage, possibly by reducing NO-bioavailability. Various
factors influence hemolysis during CPB, including the method of venous
drainage, occlusion settings, type of pump, CPB duration, arterial line
pressure, vacuum-assisted Venous drainage (VAVD) pressure, suction devices,
type of cardiac surgery, hematocrit (Hct), and patient comorbidities. However,
established standards for reducing hemolysis from CPB are lacking.
AIM
The study aims to delineate the risk factors that
increase the incidence of hemolysis and establish a safe range of parameters
according to our protocol to prevent hemolysis during CPB procedures.
METHODOLOGY
Study area: Cardiac OT of NICS
Study population: Adult Cardiac surgery patients
of NICS
Study design: Randomized Controlled
Trial
ETHICAL CLEARANCE
The study was approved by the scientific ethical
committee and Narayana Health Ethics Committee (NHH/AEC-CL-2024-1306) and
registered under the Clinical Trials Registry of India (CTRI) on 20th
December 2024 (CTRI Number: CTRI/2024/12/078407).
Conclusion:
Our study concludes that strictly adhering to the
study protocol in adult cardiac surgery patients undergoing CPB can help
prevent hemolysis and improve patient outcomes by reducing complications
associated with CPB-induced hemolysis. This applies to patients who have no
renal impairments, no hemolytic disorders, and no pre-existing hemolysis, as
well as those without cyanotic heart disease. Additionally, it is crucial that
patients do not require a return to CPB, the surgery is not a redo procedure
(particularly in cases involving mechanical valve implantation), and CPB is not
initiated as an emergency.
|