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Completed

NCT Number: NCT04231240

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

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.

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Key information

Conditions

Cardiac Event Cardiovascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Anesthésie - Réanimation de l'hôpital Louis Pradel - HCL

Bron, 69500, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measure of ACT with IStat

Device

Measure of ACT with a point of care device named IStat

Primary outcomes

  1. Agreement of ACT measurement with Istat and Hemochron

    Time frame: 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

  2. Interchangeability of ACT measurement with Istat and Hemochron

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: CHIC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2020
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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