Combined Use of a Novel Cardioplegic Formula With MPS ® Using the MiECC in Isolated CABG Versus OPCABG

Complication of Coronary Artery Bypass Graft Clinical Trial

— OPCBAG  

Official title:

Combined Use of a Novel Cardioplegic Formula With MPS ® Using the MiECC in Isolated CABG Versus OPCABG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03609723
• Other study ID #: 2018-00923; ch18reuthebuch2
• Status: Completed
• Start date: June 12, 2010
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A patient group receiving a novel cardioplegic formula with MPS ® (Myocardial protection system) and using the MiECC (Minimal extracorporeal circulation system) when undergoing coronary artery bypass grafting is compared to a retrospective patient group undergoing Off-pump coronary artery bypass grafting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2433
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• CABG using MPS® or OPCABG

Exclusion Criteria:

• use of other colloid solution than Cardioplexol ® for MPS®

• other inventions than CABG

• myocardial infarction <7 days before CABG

• patients denial of data use

Related Conditions & MeSH terms

• Complication of Coronary Artery Bypass Graft
• Complication of Extracorporeal Circulation

Intervention

Procedure:
• CABG
CABG with application of a myocardial protection system (MPS ®) and using a minimal extracorporeal circulation system (MiECC) or CABG without use of a minimal extracorporeal circulation system (Off-pump coronary artery bypass grafting = OPCABG)

Locations

Country	Name	City	State
Switzerland	Herzchirurgie University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of cardial biomarkers as high sensitive troponin T (hs-TrT), Creatinkinase (CK) and Creatinkinase myocardial type (CK-MB)	high sensitive troponin T (hs-TrT), Creatinkinase, (CK) Creatinkinase myocardial type (CK-MB)	perioperative during hospital stay for CABG
Secondary	mortality	death after coronary artery bypass grafting	30 days after CABG
Secondary	need for intensive care unit	duration of stay at intensive care unit	perioperative during hospital stay for CABG
Secondary	occurence of dysrhythmia	rhythm disturbance after CABG	perioperative during hospital stay for CABG