NCT03823521

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™

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Swiss Cardio Technologies AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Bypass Surgery
• Valve Surgery

Interventions

Type	Name	Description
DRUG	Cardioplegia Solution	Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution

Timeline

• Start date: 2018-11-20
• Primary completion: 2021-10-18
• Completion: 2021-10-18
• First posted: 2019-01-30
• Last updated: 2021-10-21

Locations

6 sites across 2 countries: Austria, Germany