Combined Use of a Novel Cardioplegic Formula With Myocardial Protection System (MPS)® Versus Cardioplexol ® in Isolated Coronary Artery Bypass Grafting (CABG) Using MiECC;
MiECC
1 other identifier
observational
211
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedFirst Submitted
Initial submission to the registry
July 17, 2018
CompletedFirst Posted
Study publicly available on registry
August 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2019
CompletedJuly 31, 2019
July 1, 2019
8.1 years
July 17, 2018
July 30, 2019
Conditions
Outcome Measures
Primary Outcomes (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)
perioperative during hospital stay for CABG
Secondary Outcomes (4)
mortality
30 days after CABG
need for intensive care unit
perioperative during hospital stay for CABG
dysrhythmia
perioperative during hospital stay for CABG
bleeding
perioperative during hospital stay for CABG
Study Arms (2)
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
cardioplegia with Cardioplexol ®
cardioplegic formula with Cardioplexol ® (colloid solution with Procaine, magnesium and potassium)
Interventions
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).
Eligibility Criteria
Patients undergoing isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system) at the department of cardial surgery University Hospital Basel Switzerland
You may qualify if:
- CABG using MPS® or Cardioplexol ®
You may not qualify if:
- use of other colloid solution than Cardioplexol ® or MPS®
- other inventions than CABG
- myocardial infarction \<7 days before CABG
- patients denial of data use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinik für Herzchirurgie, Universitätsspital Basel
Basel, 4031, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Reuthebuch, PD MD
University Hospital Basel, CH-4031 Basel
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2018
First Posted
August 2, 2018
Study Start
February 28, 2010
Primary Completion
March 31, 2018
Study Completion
March 13, 2019
Last Updated
July 31, 2019
Record last verified: 2019-07