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

NCT03823521 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2021-10-21

No results posted yet for this study

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

DRUG

Cardioplegia Solution

Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution

Sponsors & Collaborators

  • Swiss Cardio Technologies AG

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2021-10-18
Completion
2021-10-18

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03823521 on ClinicalTrials.gov