Skip to main content
OpenTrials
Completed

NCT Number: NCT03823521

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Bypass Surgery Valve Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitätsklinik Innsbruck, Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardioplegia Solution

Drug

Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution

Other names: Cardioplexol™

Primary outcomes

  1. Major Deviation in Cardioplexol application

    Time frame: During surgery

    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).

Secondary outcomes

  1. TnT Values

    Time frame: During the first 24 hours following myocardial reperfusion

    Development of concentration of blood Troponin T values measured by the local hospital laboratory

  2. CK-MB Values

    Time frame: During the first 24 hours following myocardial reperfusion

    Development of concentration of blood Creatin Kinase - isoenzyme MB (muscle-brain) values measured by the local hospital laboratory

  3. Complete Cardiac Arrest

    Time frame: During Surgery

    Time between the aortic cross-clamping and the complete cardiac arrest

  4. Catecholamine

    Time frame: During during aortic cross-clamping and during the first 24 hours

    Cumulative dose of catecholamines

  5. Defibrillation rate

    Time frame: During surgery

    Defibrillation rate after aorta unclamping and coronary reperfusion.

  6. ICU stay

    Time frame: During follow-up phase after surgery up to 35 days

    Duration of ICU stay

  7. Mortality

    Time frame: During the first 24 hours following coronary reperfusion

    Number of patients, who died

Sponsors and collaborators

Lead sponsor

Swiss Cardio Technologies AG

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 30, 2019
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.