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

July 31, 2019 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2433

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Herzchirurgie University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of cardial biomarkers as high sensitive troponin T (hs-TrT), Creatinkinase (CK) and Creatinkinase myocardial type (CK-MB)
Time Frame: perioperative during hospital stay for CABG
high sensitive troponin T (hs-TrT), Creatinkinase, (CK) Creatinkinase myocardial type (CK-MB)
perioperative during hospital stay for CABG

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 30 days after CABG
death after coronary artery bypass grafting
30 days after CABG
need for intensive care unit
Time Frame: perioperative during hospital stay for CABG
duration of stay at intensive care unit
perioperative during hospital stay for CABG
occurence of dysrhythmia
Time Frame: perioperative during hospital stay for CABG
rhythm disturbance after CABG
perioperative during hospital stay for CABG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Oliver Reuthebuch, PD MD, Klinik für Herzchirurgie, Universitätsspital Basel Spitalstrasse 21 4031 Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2010

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

July 17, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-00923; ch18reuthebuch2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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