NCT04231240

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Cardiac Event

Interventions

Type	Name	Description
DEVICE	Measure of ACT with IStat	Measure of ACT with a point of care device named IStat

Timeline

• Start date: 2020-07-17
• Primary completion: 2021-03-02
• Completion: 2021-03-02
• First posted: 2020-01-18
• Last updated: 2021-06-08

Locations

1 site across 1 country: France