Coronary Artery Bypass SurgeryPhase 3NCT03823521
Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™
A Phase 3 study testing Cardioplegia Solution in people with Coronary Artery Bypass Surgery and Valve Surgery, run by Swiss Cardio Technologies AG at 6 sites in 2 countries.
Trial summary
This is a multi-center, open label, single group, observational study designed to evaluate the effects of a Cardioplexol™ preparation and administration training program proposed to cardiac surgeons and cardiotechnicians inexperienced in the use of Cardioplexol™. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Bypass Surgery, Valve Surgery
- What is being tested?
- Cardioplegia Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 20 Nov 2018to 18 Oct 2021
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between 18 and 80 years of age;
- The patient's pre-operative evaluation indicates the need for a primary elective cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve repair/replacement;
- The operation can be carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine;
- Patients who provide signed written informed consent.
Who cannot join
- Pre-operative EF of less than 30%;
- Pre-operative IABP;
- Pre-operative catecholamine support;
- History of myocardial infarction within less than 7 days;
- Previous history of cardiac surgery, including the implantation of a pace maker or an ICD;
- Active myocarditis and/or endocarditis;
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- Aortic valve insufficiency severity grade more than 1;
- Under dialysis;
- Pre-operative serum creatinine value of more than 2.0 mg/dl;
- Known hematologic disorder;
- Treatment with anti-vitamin K;
- History of HIT;
- Participating in a concomitant research study of an investigational product;
- Pregnant or lactating;
- Intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Austria4 sites
Universitätsklinik Innsbruck
Innsbruck, 6020
Universitaetsklinikum Salzburg
Salzburg, 5020
Universitaetsklnikum St. Pölten
Sankt Pölten, 3100
Krankenhaus Hietzing
Vienna, 1130
Germany2 sites
Deutsches Herzzentrum Berlin
Berlin, 13353
Universitaetsklinikum Frankfurt
Frankfurt, 60590
About this study
Official title: A Multi-Center, Open Label, Single Group, Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™
This is a multi-center, open label, single group, observational study designed to evaluate the effects of a Cardioplexol™ preparation and administration training program proposed to cardiac surgeons and cardiotechnicians inexperienced in the use of Cardioplexol™.
The training program aims at increasing the efficacy of Cardioplexol administration while reducing the risk of false manipulations. During the training possible risks and consequences of incorrect applications as well as the measures to take in case of administration error, are discussed. The training program includes one standardized theoretical part and one practical part consisting of a direct intra-operative coaching of surgeons practicing their first 2 operations.
The effect of the training will then be assessed by evaluating each trained surgeon's 4 next consecutive patients operated with Cardioplexol and without the coach.
- Conditions
- Coronary Artery Bypass Surgery, Valve Surgery
- Being tested
- Cardioplegia Solution
- Keywords
- Cardioplegic Solutions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardioplegia SolutionDrug
Also called Cardioplexol™
Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution
| Study group | Role | What they receive |
|---|---|---|
| Cardioplexol™- Cardioplegia Solution | Experimental | Cardioplexol™ will be used as cardioplegic solution in cardiac surgery Receives: Drug: Cardioplegia Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Deviation in Cardioplexol application
Number of major deviations from the application of Cardioplexol™ as determined by the pre-specified training documentation (incorrect volume of initial dose, incorrect volume of second/third/fourth dose, incorrect duration of injection of initial dose, incorrect timing of application of initial dose, incorrect timing of application of second/third/fourth dose).
Measured: During surgery
Secondary outcomes (7)
TnT Values
Development of concentration of blood Troponin T values measured by the local hospital laboratory
Measured: During the first 24 hours following myocardial reperfusion
CK-MB Values
Development of concentration of blood Creatin Kinase - isoenzyme MB (muscle-brain) values measured by the local hospital laboratory
Measured: During the first 24 hours following myocardial reperfusion
Complete Cardiac Arrest
Time between the aortic cross-clamping and the complete cardiac arrest
Measured: During Surgery
Catecholamine
Cumulative dose of catecholamines
Measured: During during aortic cross-clamping and during the first 24 hours
Defibrillation rate
Defibrillation rate after aorta unclamping and coronary reperfusion.
Measured: During surgery
ICU stay
Duration of ICU stay
Measured: During follow-up phase after surgery up to 35 days
Mortality
Number of patients, who died
Measured: During the first 24 hours following coronary reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start20 Nov 2018
- Primary completion18 Oct 2021
- Study completion18 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cardio Technologies AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823521
- Sponsor's protocol ID
- SCT-Cpx-004
- Status last verified
- Oct 2021
- First submitted
- 27 Jan 2019
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tevaearai Stahel HT, Taheri N, Winkler A, Hohlfeld J, Dietl W, Starck C, Van Linden A, Bidovec J, Imhof A, Carrel TP, Voet B, Walther T, Seitelberger R, Grimm M, Holzinger C, Grabenwoger M. A multi-center, open label, single group, observational clinical trial to investigate the effects of training on the administration of Cardioplexol. Front Cardiovasc Med. 2025 May 26;12:1588088. doi: 10.3389/fcvm.2025.1588088. eCollection 2025.
PubMed 40491721
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open Label, Single Group, Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™
- ClinicalTrials.gov ID
- NCT03823521
- Acronym / sponsor ID
- SCT-Cpx-004
- Conditions
- Coronary Artery Bypass Surgery, Valve Surgery
- Keywords
- Cardioplegic Solutions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Swiss Cardio Technologies AGIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 30 Jan 2019 (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.
This is a multi-center, open label, single group, observational study designed to evaluate the effects of a Cardioplexol™ preparation and administration training program proposed to cardiac surgeons and cardiotechnicians inexperienced in the use of Cardioplexol™.
The training program aims at increasing the efficacy of Cardioplexol administration while reducing the risk of false manipulations. During the training possible risks and consequences of incorrect applications as well as the measures to take in case of administration error, are discussed. The training program includes one standardized theoretical part and one practical part consisting of a direct intra-operative coaching of surgeons practicing their first 2 operations.
The effect of the training will then be assessed by evaluating each trained surgeon's 4 next consecutive patients operated with Cardioplexol and without the coach.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardioplexol™- Cardioplegia Solution | Experimental | Drug: Cardioplegia SolutionCardioplexol™ will be used as cardioplegic solution in cardiac surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients between 18 and 80 years of age;
- The patient's pre-operative evaluation indicates the need for a primary elective cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve repair/replacement;
- The operation can be carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine;
- Patients who provide signed written informed consent.
Key exclusion criteria (15 listed)
- Pre-operative EF of less than 30%;
- Pre-operative IABP;
- Pre-operative catecholamine support;
- History of myocardial infarction within less than 7 days;
- Previous history of cardiac surgery, including the implantation of a pace maker or an ICD;
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 |
|---|---|---|
| Cardioplegia SolutionAlso: Cardioplexol™Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution | Drug | Cardioplexol™- Cardioplegia Solution |
Primary outcome
Major Deviation in Cardioplexol application
Time frame: During surgery
Number of major deviations from the application of Cardioplexol™ as determined by the pre-specified training documentation (incorrect volume of initial dose, incorrect volume of second/third/fourth dose, incorrect duration of injection of initial dose, incorrect timing of application of initial dose, incorrect timing of application of second/third/fourth dose).
7 secondary outcomes
TnT Values
Time frame: During the first 24 hours following myocardial reperfusion
CK-MB Values
Time frame: During the first 24 hours following myocardial reperfusion
Complete Cardiac Arrest
Time frame: During Surgery
Catecholamine
Time frame: During during aortic cross-clamping and during the first 24 hours
Defibrillation rate
Time frame: During surgery
ICU stay
Time frame: During follow-up phase after surgery up to 35 days
Mortality
Time frame: During the first 24 hours following coronary reperfusion
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 21 Oct 2021.
- Derived from this study: PubMed 40491721Tevaearai Stahel HT, Taheri N, Winkler A, Hohlfeld J, Dietl W, Starck C, Van Linden A, Bidovec J, Imhof A, Carrel TP, Voet B, Walther T, Seitelberger R, Grimm M, Holzinger C, Grabenwoger M. A multi-center, open label, single group, observational clinical trial to investigate the effects of training on the administration of Cardioplexol. Front Cardiovasc Med. 2025 May 26;12:1588088. doi: 10.3389/fcvm.2025.1588088. eCollection 2025.
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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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cardioplegia Solution in people with Coronary Artery Bypass Surgery and Valve Surgery, run by Swiss Cardio Technologies AG at 6 sites in 2 countries.
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 4 inclusion and 15 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 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria, Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Major Deviation in Cardioplexol application (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03823521, which also lists 1 linked publication.
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 21 Oct 2021.