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临床试验/CTRI/2025/08/092390
CTRI/2025/08/092390尚未招募不适用

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 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2025年8月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
402
试验地点
1
主要终点
Incidence of Hemolysis

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Incidence of Hemolysis

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

次要结局

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

研究者

发起方
D E Nirman Kanna
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

D E Nirman Kanna

Narayana Hrudayalaya Foundations

研究点 (1)

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