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

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ClinicalTrials.gov Identifier: NCT04231240
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

Condition or disease Intervention/treatment
Cardiac Event 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Hemochron and Istat in Cardiac Surgery (CHIC Study)
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04231240


Contacts
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Contact: Laurent CHARDONNAL, Dr 04 72 11 89 53 ext +33 Laurent.chardonnal@chu-lyon.fr
Contact: Jean-Luc FELLAHI, Pr 04 72 11 89 33 ext +33 Jean-Luc.fellahi@chu-lyon.fr

Locations
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France
Service d'Anesthésie - Réanimation de l'hôpital Louis Pradel - HCL
Bron, France, 69500
Contact: Laurent CHARDONNAL, Dr    04 72 11 89 53 ext +33    Laurent.chardonnal@chu-lyon.fr   
Contact: Jean Luc FELLAHI, Pr    04 72 11 89 33 ext +33    Jean-Luc.fellahi@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04231240    
Other Study ID Numbers: 69HCL19_0381
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No