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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Event
• Intervention / Treatment: Device: Measure of ACT with IStat

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Service d'Anesthésie - Réanimation de l'hôpital Louis Pradel - HCL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults and children with cardiac surgery with or without cardiopulmonary bypass supported in the Department of Anesthesia - Resuscitation of the Louis Pradel Hospital (Lyon, France).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult cardiac surgery with normothermia	Device: Measure of ACT with IStat; Measure of ACT with a point of care device named IStat
Adult cardiac surgery with hypothermia	Device: Measure of ACT with IStat; Measure of ACT with a point of care device named IStat
Pediatric cardiac surgery with normothermia	Device: Measure of ACT with IStat; Measure of ACT with a point of care device named IStat
Pediatric cardiac surgery with hypothermia	Device: Measure of ACT with IStat; Measure of ACT with a point of care device named IStat
Adult cardiac surgery without cardiopulmonary bypass	Device: Measure of ACT with IStat; Measure of ACT with a point of care device named IStat

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Actual): March 2, 2021
• Study Completion (Actual): March 2, 2021

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL19_0381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No