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

NCT04231240 | Completed

• 1 other identifier: 69HCL19_0381
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Event

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (5)

Adult cardiac surgery with normothermia

Device: Measure of ACT with IStat

Adult cardiac surgery with hypothermia

Device: Measure of ACT with IStat

Pediatric cardiac surgery with normothermia

Device: Measure of ACT with IStat

Pediatric cardiac surgery with hypothermia

Device: Measure of ACT with IStat

Adult cardiac surgery without cardiopulmonary bypass

Device: Measure of ACT with IStat

Interventions

Measure of ACT with IStat DEVICE

Measure of ACT with a point of care device named IStat

Adult cardiac surgery with hypothermia; Adult cardiac surgery with normothermia; Adult cardiac surgery without cardiopulmonary bypass; Pediatric cardiac surgery with hypothermia; Pediatric cardiac surgery with normothermia

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• patient with heparin-induced thrombocytopenia
• patient receiving antiplatelet therapy targeting GpIIbIIIa receptors

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69500, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: July 17, 2020
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)