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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03823521
Other study ID # SCT-Cpx-004
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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