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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Switzerland

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 groups in NCT03612388
Study groupRoleWhat 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.

  1. 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)
  1. mortality

    death after coronary artery bypass grafting

    Measured: 30 days after CABG

  2. need for intensive care unit

    duration of stay at intensive care unit

    Measured: perioperative during hospital stay for CABG

  3. dysrhythmia

    rhythm disturbance after coronary artery bypass grafting

    Measured: perioperative during hospital stay for CABG

  4. 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.

  1. First posted2 Aug 2018
  2. Study start28 Feb 2010
  3. Primary completion31 Mar 2018
  4. Study completion13 Mar 2019

Resources

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)
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

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.

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