Complication of Extracorporeal CirculationMiECCNCT03612388
Combined Use of a Novel Cardioplegic Formula With Myocardial Protection System (MPS)® Versus Cardioplexol ® in Isolated Coronary Artery Bypass Grafting (CABG) Using MiECC;
An observational study of Complication of Extracorporeal Circulation and Complication of Coronary Artery Bypass Graft, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Combined use of a novel cardioplegic formula with MPS® (Myocardial protection system) versus Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complication of Extracorporeal Circulation, Complication of Coronary Artery Bypass Graft
- What is being tested?
- use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation
- Type of treatment
- Surgery or procedure
- How many people
- 211 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Feb 2010to 13 Mar 2019
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system) at the department of cardial surgery University Hospital Basel Switzerland
Who may be able to join
- CABG using MPS® or Cardioplexol ®
Who cannot join
- use of other colloid solution than Cardioplexol ® or MPS®
- other inventions than CABG
- myocardial infarction <7 days before CABG
- patients denial of data use
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Herzchirurgie, Universitätsspital Basel
Basel, 4031
About this study
Official title: Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Isolated CABG Using MiECC (Minimal Extracorporeal Circulation System)
Combined use of a novel cardioplegic formula with MPS® (Myocardial protection system) versus Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system).
- Being tested
- use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulationProcedure or surgery
use of a novel cardioplegic formula with MPS® (Myocardial protection system) versus Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system).
| Study group | Role | What they receive |
|---|---|---|
| cardioplegia with MPS® (Myocardial protection system) | cardioplegic formula with MPS® (Myocardial protection system); use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation Receives: Procedure: use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation | |
| cardioplegia with Cardioplexol ® | cardioplegic formula with Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lab values for cardial biomarkers
cardial biomarkers measured are high sensitive troponin T (hs-TrT), Creatinkinase, (CK) Creatinkinase myocardial type (CK-MB)
Measured: perioperative during hospital stay for CABG
Secondary outcomes (4)
mortality
death after coronary artery bypass grafting
Measured: 30 days after CABG
need for intensive care unit
duration of stay at intensive care unit
Measured: perioperative during hospital stay for CABG
dysrhythmia
rhythm disturbance after coronary artery bypass grafting
Measured: perioperative during hospital stay for CABG
bleeding
bleeding complication after coronary artery bypass grafting
Measured: perioperative during hospital stay for CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start28 Feb 2010
- Primary completion31 Mar 2018
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Extracorporeal CirculationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Reuthebuch, PD MD, Principal investigator, University Hospital Basel, CH-4031 Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612388
- Sponsor's protocol ID
- 2018-00926; ch18Reuthebuch3
- Other IDs
- 2018
- Acronym
- MiECC
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2018
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Isolated CABG Using MiECC (Minimal Extracorporeal Circulation System)
- ClinicalTrials.gov ID
- NCT03612388
- Acronym / sponsor ID
- MiECC / 2018-00926; ch18Reuthebuch3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 28 Feb 2010 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 2 Aug 2018 (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.
Combined use of a novel cardioplegic formula with MPS® (Myocardial protection system) versus Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardioplegia with MPS® (Myocardial protection system) | – | Procedure: use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulationcardioplegic formula with MPS® (Myocardial protection system); use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation |
| cardioplegia with Cardioplexol ® | – | –cardioplegic formula with Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system) at the department of cardial surgery University Hospital Basel Switzerland
Key inclusion criteria (1 listed)
- CABG using MPS® or Cardioplexol ®
Key exclusion criteria (4 listed)
- use of other colloid solution than Cardioplexol ® or MPS®
- other inventions than CABG
- myocardial infarction <7 days before CABG
- patients denial of data use
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 |
|---|---|---|
| use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulationuse of a novel cardioplegic formula with MPS® (Myocardial protection system) versus Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system). | Procedure or surgery | cardioplegia with MPS® (Myocardial protection system) |
Primary outcome
Change in lab values for cardial biomarkers
Time frame: perioperative during hospital stay for CABG
cardial biomarkers measured are high sensitive troponin T (hs-TrT), Creatinkinase, (CK) Creatinkinase myocardial type (CK-MB)
4 secondary outcomes
mortality
Time frame: 30 days after CABG
need for intensive care unit
Time frame: perioperative during hospital stay for CABG
dysrhythmia
Time frame: perioperative during hospital stay for CABG
bleeding
Time frame: perioperative during hospital stay for CABG
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 31 Jul 2019.
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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.
Oliver Reuthebuch, PD MD principal investigator
University Hospital Basel, CH-4031 Basel
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 Complication of Extracorporeal Circulation and Complication of Coronary Artery Bypass Graft, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 4 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 31 Jul 2019. 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 Switzerland. 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?
Change in lab values for cardial biomarkers (time frame: perioperative during hospital stay for CABG). 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 31 Jul 2019.