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

NCT03609723 | Completed

• 1 other identifier: 2018-00923; ch18reuthebuch2
• Study Type: observational
• Target: 2,433
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Complication of Coronary Artery Bypass Graft; Complication of Extracorporeal Circulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• mortality

  30 days after CABG

• need for intensive care unit

  perioperative during hospital stay for CABG

• occurence of dysrhythmia

  perioperative during hospital stay for CABG

Study Arms (2)

MPS® in patients with CABG

Patients undergoing coronary artery bypass grafting with application of a myocardial protection system (MPS ®) and using a minimal extracorporeal circulation system (MiECC)

Procedure: CABG

OPCABG in patients with CABG

Patients undergoing coronary artery bypass grafting without use of a minimal extracorporeal circulation system (Off-pump coronary artery bypass grafting = OPCABG)

Procedure: CABG

Interventions

CABG PROCEDURE

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)

MPS® in patients with CABG; OPCABG in patients with CABG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• CABG using MPS® or OPCABG

You may not qualify if:

• use of other colloid solution than Cardioplexol ® for MPS®
• other inventions than CABG
• myocardial infarction \<7 days before CABG
• patients denial of data use

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Herzchirurgie University Hospital Basel

Basel, 4031, Switzerland

Location

Study Officials

• Oliver Reuthebuch, PD MD

  Klinik für Herzchirurgie, Universitätsspital Basel Spitalstrasse 21 4031 Basel

  PRINCIPAL INVESTIGATOR

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 1, 2018
• Study Start: June 12, 2010
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

CH (1)