Correlation Between Hemochron and Istat in Cardiac Surgery (CHIC Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Interchangeability of ACT measurement with Istat and Hemochron
研究概览
简要总结
Cardiac surgery needs the use of cardiopulmonary bypass. During this time, it is necessary to prevent thrombosis with high level of heparin and to control the good efficiency with a point of care test. Investigators want to test if two different devices, Hemochron and Istat, are giving similar results.
详细描述
The management of the extracorporeal circulation (ECC) for cardiac surgery requires massive anticoagulation of the circuit by heparinization at 300 IU / kg of unfractionated heparin (HNF). To ensure an adequate level of safety, it is necessary to monitor the effectiveness of this dose of NHF. Several point of care monitors measuring activated coagulation time (ACT) are available on the market. Among these are the Hemochron (currently used routinely in the institution) and the IStat. These two monitors have been compared in adult cardiac surgery without deep hypothermia, but there is no comparative study in pediatric cardiac surgery.
The result of the ACT being dependent, in addition to heparinization, the platelet count, the fibrinogen level and the body temperature, it is therefore necessary to test the approval and the interchangeability between the monitors in different clinical situations .
The objective of this study is to reproduce the results published in adults and to compare these two monitors in pediatrics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults or children
- •Supported in the Department of Anesthesia - Resuscitation of the Louis Pradel Hospital (Lyon, France) for cardiac surgery with or without cardiopulmonary bypass
- •Patient or Parents / Holders of parental authority informed and not opposed to participate in the study
排除标准
- •patient with heparin-induced thrombocytopenia
- •patient receiving antiplatelet therapy targeting GpIIbIIIa receptors
结局指标
主要结局
Interchangeability of ACT measurement with Istat and Hemochron
时间窗: Maximum 6 hours (time of surgery)
Investigators will use linear regression correlation, ROC curves analysis Istat and Hemochron will be measured at 5 time points : * induction, * 2 minutes after heparin loading, * 10 minutes after the stat of cardiopulmonary bypass or after heparin, * 30 minutes after the start of cardiopulmonary bypass or after heparin, * 2 minutes after protamin
Agreement of ACT measurement with Istat and Hemochron
时间窗: Maximum 6 hours (time of surgery)
Investigators will use linear regression correlation, ROC curves analysis Istat and Hemochron will be measured at 5 time points : * induction, * 2 minutes after heparin loading, * 10 minutes after the stat of cardiopulmonary bypass or after heparin, * 30 minutes after the start of cardiopulmonary bypass or after heparin, * 2 minutes after protamin
次要结局
未报告次要终点