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A comparative study on Haemolysis strategies During Cardiopulmonary Bypass on Adult Cardiac Surgeries

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 - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092390
Enrollment
402
Registered
2025-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I71- Aortic aneurysm and dissection Health Condition 2: I251- Atherosclerotic heart disease of native coronary artery Health Condition 3: I080- Rheumatic disorders of both mitraland aortic valves

Interventions

Intervention1: 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

Sponsors

D E Nirman Kanna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult Cardiac surgeries that require the use of cardiopulmonary and CPB time of more than 60 minutes of bypass

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Incidence of HemolysisTimepoint: Itra Operative (60mins after CPB ON) and Post Operative period (24hrs after CPB OFF) POD 1—

Secondary

MeasureTime frame
To delineate the risk factors that increase the incidence of hemolysisTimepoint: Itra Operative (60mins after CPB ON) and Post Operative period (24hrs after CPB OFF) POD 1—

Countries

India

Contacts

Public ContactDr Varun Shetty

Narayana Institute Of Cardiac Sciences

varun.shetty.dr@narayanahealth.org9880933801

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026