Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™

Phase 3

Completed

• Conditions: Coronary Artery Bypass Surgery; Valve Surgery
• Interventions: Drug: Cardioplegia Solution

• Registration Number: NCT03823521
• Lead Sponsor: Swiss Cardio Technologies AG

Brief Summary

This is a multi-center, open label, single group, observational study designed to evaluate the effects of a Cardioplexol™ preparation and administration training program proposed to cardiac surgeons and cardiotechnicians inexperienced in the use of Cardioplexol™.

The training program aims at increasing the efficacy of Cardioplexol administration while reducing the risk of false manipulations. During the training possible risks and consequences of incorrect applications as well as the measures to take in case of administration error, are discussed. The training program includes one standardized theoretical part and one practical part consisting of a direct intra-operative coaching of surgeons practicing their first 2 operations.

The effect of the training will then be assessed by evaluating each trained surgeon's 4 next consecutive patients operated with Cardioplexol and without the coach.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-20
• Study First Submitted: 2019-01-27
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-30
• Status Verified: 2021-10
• Primary Completion: 2021-10-18
• Study Completion: 2021-10-18
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

• Male or female patients between 18 and 80 years of age;
• The patient's pre-operative evaluation indicates the need for a primary elective cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve repair/replacement;
• The operation can be carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine;
• Patients who provide signed written informed consent.

Exclusion Criteria

• Pre-operative EF of less than 30%;
• Pre-operative IABP;
• Pre-operative catecholamine support;
• History of myocardial infarction within less than 7 days;
• Previous history of cardiac surgery, including the implantation of a pace maker or an ICD;
• Active myocarditis and/or endocarditis;
• Aortic valve insufficiency severity grade more than 1;
• Under dialysis;
• Pre-operative serum creatinine value of more than 2.0 mg/dl;
• Known hematologic disorder;
• Treatment with anti-vitamin K;
• History of HIT;
• Participating in a concomitant research study of an investigational product;
• Pregnant or lactating;
• Intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardioplexol™- Cardioplegia Solution	Cardioplegia Solution	Cardioplexol™ will be used as cardioplegic solution in cardiac surgery

Primary Outcome Measures

Name	Time	Method
Major Deviation in Cardioplexol application	During surgery	Number of major deviations from the application of Cardioplexol™ as determined by the pre-specified training documentation (incorrect volume of initial dose, incorrect volume of second/third/fourth dose, incorrect duration of injection of initial dose, incorrect timing of application of initial dose, incorrect timing of application of second/third/fourth dose).

Secondary Outcome Measures

Name	Time	Method
TnT Values	During the first 24 hours following myocardial reperfusion	Development of concentration of blood Troponin T values measured by the local hospital laboratory
Complete Cardiac Arrest	During Surgery	Time between the aortic cross-clamping and the complete cardiac arrest
Catecholamine	During during aortic cross-clamping and during the first 24 hours	Cumulative dose of catecholamines
ICU stay	During follow-up phase after surgery up to 35 days	Duration of ICU stay
Mortality	During the first 24 hours following coronary reperfusion	Number of patients, who died
CK-MB Values	During the first 24 hours following myocardial reperfusion	Development of concentration of blood Creatin Kinase - isoenzyme MB (muscle-brain) values measured by the local hospital laboratory
Defibrillation rate	During surgery	Defibrillation rate after aorta unclamping and coronary reperfusion.

Trial Locations

Locations (6)

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Universitaetsklnikum St. Pölten; 🇦🇹 St. Pölten, Austria

Universitaetsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Krankenhaus Hietzing; 🇦🇹 Wien, Austria

Universitätsklinik Innsbruck; 🇦🇹 Innsbruck, Austria

Universitaetsklinikum Salzburg; 🇦🇹 Salzburg, Austria