Clinical trial NCT03823521: Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™
Official title: A Multi-Center, Open Label, Single Group, Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Bypass Surgery
Valve Surgery
Keywords: Cardioplegic Solutions
Lead sponsor: Swiss Cardio Technologies AG
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major Deviation in Cardioplexol application
timeFrame: During surgery
Secondary outcomes:
measure: TnT Values
timeFrame: During the first 24 hours following myocardial reperfusion
measure: CK-MB Values
timeFrame: During the first 24 hours following myocardial reperfusion
measure: Complete Cardiac Arrest
timeFrame: During Surgery
measure: Catecholamine
timeFrame: During during aortic cross-clamping and during the first 24 hours
measure: Defibrillation rate
timeFrame: During surgery
measure: ICU stay
timeFrame: During follow-up phase after surgery up to 35 days
measure: Mortality
timeFrame: During the first 24 hours following coronary reperfusion
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck
city: Salzburg
country: Austria
facility: Universitaetsklinikum Salzburg
city: St. Pölten
country: Austria
facility: Universitaetsklnikum St. Pölten
city: Wien
country: Austria
facility: Krankenhaus Hietzing
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt
Study officials:
References: