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

Swiss Cardio Technologies

Status and phase

Completed

Phase 3

Conditions

Valve Surgery

Coronary Artery Bypass Surgery

Treatments

Drug: Cardioplegia Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT03823521

SCT-Cpx-004

Details and patient eligibility

About

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.

Enrollment

171 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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