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

Civil Hospices of Lyon

Status: Completed

Conditions: Cardiac Event

Treatments: Device: Measure of ACT with IStat

Study type: Observational

Funder types: Other

Identifiers

NCT04231240

69HCL19_0381

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 5 patient groups

Adult cardiac surgery with normothermia

Treatment:

Device: Measure of ACT with IStat

Adult cardiac surgery with hypothermia

Treatment:

Device: Measure of ACT with IStat

Pediatric cardiac surgery with normothermia

Treatment:

Device: Measure of ACT with IStat

Pediatric cardiac surgery with hypothermia

Treatment:

Device: Measure of ACT with IStat

Adult cardiac surgery without cardiopulmonary bypass

Treatment:

Device: Measure of ACT with IStat