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

Coronary Artery Bypass Surgery Clinical Trial

Official title:

A Multi-Center, Open Label, Single Group, Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823521
• Other study ID #: SCT-Cpx-004
• Status: Completed
• Phase: Phase 3
• Start date: November 20, 2018
• Est. completion date: October 18, 2021

Study information

• Verified date: October 2021
• Source: Swiss Cardio Technologies AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: October 18, 2021
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Surgery
• Valve Surgery

Intervention

Drug:
• Cardioplegia Solution
Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution

Locations

Country	Name	City	State
Austria	Universitätsklinik Innsbruck	Innsbruck
Austria	Universitaetsklinikum Salzburg	Salzburg
Austria	Universitaetsklnikum St. Pölten	St. Pölten
Austria	Krankenhaus Hietzing	Wien
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Universitaetsklinikum Frankfurt	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Cardio Technologies AG

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

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