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

Completed

• Conditions: Cardiac Event
• Interventions: Device: Measure of ACT with IStat

• Registration Number: NCT04231240
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Study Start: 2020-07-17
• Primary Completion: 2021-03-02
• Study Completion: 2021-03-02
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• patient with heparin-induced thrombocytopenia
• patient receiving antiplatelet therapy targeting GpIIbIIIa receptors

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult cardiac surgery with hypothermia	Measure of ACT with IStat	-
Adult cardiac surgery without cardiopulmonary bypass	Measure of ACT with IStat	-
Adult cardiac surgery with normothermia	Measure of ACT with IStat	-
Pediatric cardiac surgery with normothermia	Measure of ACT with IStat	-
Pediatric cardiac surgery with hypothermia	Measure of ACT with IStat	-

Primary Outcome Measures

Name	Time	Method
Interchangeability of ACT measurement with Istat and Hemochron	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	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

Trial Locations

Locations (1)

Service d'Anesthésie - Réanimation de l'hôpital Louis Pradel - HCL; 🇫🇷 Bron, France