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

NCT ID: NCT04231240

Last Updated: 2021-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-17

Study Completion Date

2021-03-02

Brief Summary

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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

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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

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Cardiac Event

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult cardiac surgery with normothermia

Measure of ACT with IStat

Intervention Type DEVICE

Measure of ACT with a point of care device named IStat

Adult cardiac surgery with hypothermia

Measure of ACT with IStat

Intervention Type DEVICE

Measure of ACT with a point of care device named IStat

Pediatric cardiac surgery with normothermia

Measure of ACT with IStat

Intervention Type DEVICE

Measure of ACT with a point of care device named IStat

Pediatric cardiac surgery with hypothermia

Measure of ACT with IStat

Intervention Type DEVICE

Measure of ACT with a point of care device named IStat

Adult cardiac surgery without cardiopulmonary bypass

Measure of ACT with IStat

Intervention Type DEVICE

Measure of ACT with a point of care device named IStat

Interventions

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Measure of ACT with IStat

Measure of ACT with a point of care device named IStat

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Bron, , France

Site Status

Countries

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France

Other Identifiers

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69HCL19_0381

Identifier Type: -

Identifier Source: org_study_id

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