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

Cardiac Event Clinical Trial

— CHIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04231240
• Other study ID #: 69HCL19_0381
• Status: Completed
• Start date: July 17, 2020
• Est. completion date: March 2, 2021

Study information

• Verified date: June 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2, 2021
• Est. primary completion date: March 2, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Event

Intervention

Device:
• Measure of ACT with IStat
Measure of ACT with a point of care device named IStat

Locations

Country	Name	City	State
France	Service d'Anesthésie - Réanimation de l'hôpital Louis Pradel - HCL	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)