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Clinical Trials/CTRI/2025/08/092390
CTRI/2025/08/092390
Not yet recruiting
Not Applicable

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

D E Nirman Kanna1 site in 1 country402 target enrollmentStarted: August 28, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
D E Nirman Kanna
Enrollment
402
Locations
1
Primary Endpoint
Incidence of Hemolysis

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Adult Cardiac surgeries that require the use of cardiopulmonary and CPB time of more than 60 minutes of bypass.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Incidence of Hemolysis

Time Frame: Itra Operative (60mins after CPB ON) and Post | Operative period (24hrs after CPB OFF) POD 1

Secondary Outcomes

  • To delineate the risk factors that increase the(incidence of hemolysis)

Investigators

Sponsor
D E Nirman Kanna
Sponsor Class
Private hospital/clinic
Responsible Party
Principal Investigator
Principal Investigator

D E Nirman Kanna

Narayana Hrudayalaya Foundations

Study Sites (1)

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