Cardiac EventCHICNCT04231240
Correlation Between Hemochron and Istat in Cardiac Surgery (CHIC Study)
An observational study of Cardiac Event, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Event
- What is being tested?
- Measure of ACT with IStat
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2020to 2 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- patient with heparin-induced thrombocytopenia
- patient receiving antiplatelet therapy targeting GpIIbIIIa receptors
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Anesthésie - Réanimation de l'hôpital Louis Pradel - HCL
Bron, 69500
About this 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.
Read the 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.
- Conditions
- Cardiac Event
- Being tested
- Measure of ACT with IStat
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of ACT with IStatDevice
Measure of ACT with a point of care device named IStat
| Study group | Role | What they receive |
|---|---|---|
| Adult cardiac surgery with normothermia | Not described Receives: Device: Measure of ACT with IStat | |
| Adult cardiac surgery with hypothermia | Not described Receives: Device: Measure of ACT with IStat | |
| Pediatric cardiac surgery with normothermia | Not described Receives: Device: Measure of ACT with IStat | |
| Pediatric cardiac surgery with hypothermia | Not described Receives: Device: Measure of ACT with IStat | |
| Adult cardiac surgery without cardiopulmonary bypass | Not described Receives: Device: Measure of ACT with IStat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Maximum 6 hours (time of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start17 Jul 2020
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac EventStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231240
- Sponsor's protocol ID
- 69HCL19_0381
- Acronym
- CHIC
- Status last verified
- Jun 2021
- First submitted
- 13 Jan 2020
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Hemochron and Istat in Cardiac Surgery (CHIC Study)
- ClinicalTrials.gov ID
- NCT04231240
- Acronym / sponsor ID
- CHIC / 69HCL19_0381
- Conditions
- Cardiac Event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- patient with heparin-induced thrombocytopenia
- patient receiving antiplatelet therapy targeting GpIIbIIIa receptors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of ACT with IStatMeasure of ACT with a point of care device named IStat | Device | 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 |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Event, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of ACT measurement with Istat and Hemochron (time frame: Maximum 6 hours (time of surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.