Correlation Between Hemochron and Istat in Cardiac Surgery (CHIC Study)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Correlation Between Hemochron and Istat in Cardiac Surgery (CHIC Study)

Conditions
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Cardiac Event

Intervention / Treatment
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* Device: Measure of ACT with IStat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: patient with heparin-induced thrombocytopenia patient receiving antiplatelet therapy targeting GpIIbIIIa receptors
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult cardiac surgery with normothermia<br> | Device: Measure of ACT with IStat<br>* Measure of ACT with a point of care device named IStat<br>|
| Adult cardiac surgery with hypothermia<br> | Device: Measure of ACT with IStat<br>* Measure of ACT with a point of care device named IStat<br>|
| Pediatric cardiac surgery with normothermia<br> | Device: Measure of ACT with IStat<br>* Measure of ACT with a point of care device named IStat<br>|
| Pediatric cardiac surgery with hypothermia<br> | Device: Measure of ACT with IStat<br>* Measure of ACT with a point of care device named IStat<br>|
| Adult cardiac surgery without cardiopulmonary bypass<br> | Device: Measure of ACT with IStat<br>* Measure of ACT with a point of care device named IStat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement of ACT measurement with Istat and Hemochron | 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 | Maximum 6 hours (time of surgery) | 
| Interchangeability of ACT measurement with Istat and Hemochron | 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 | Maximum 6 hours (time of surgery) |