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

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

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.

Study Overview

• Status: Completed
• Conditions: Valve Surgery; Coronary Artery Bypass Surgery
• Intervention / Treatment: Drug: Cardioplegia Solution

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Universitätsklinik Innsbruck
  • Salzburg, Austria, 5020
    • Universitaetsklinikum Salzburg
  • St. Pölten, Austria, 3100
    • Universitaetsklnikum St. Pölten
  • Wien, Austria, 1130
    • Krankenhaus Hietzing
• Germany
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Frankfurt, Germany, 60590
    • Universitaetsklinikum Frankfurt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardioplexol™- Cardioplegia Solution; Cardioplexol™ will be used as cardioplegic solution in cardiac surgery	Drug: Cardioplegia Solution; Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution; Other Names: Cardioplexol™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Swiss Cardio Technologies AG

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): October 18, 2021
• Study Completion (Actual): October 18, 2021

Study Registration Dates

• First Submitted: January 27, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Cardioplegic Solutions
• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Cardioplegic Solutions
• Other Study ID Numbers: SCT-Cpx-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No