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

NCT ID: NCT03823521

Last Updated: 2021-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2021-10-18

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cardioplexol™- Cardioplegia Solution

Cardioplexol™ will be used as cardioplegic solution in cardiac surgery

Group Type: EXPERIMENTAL

Cardioplegia Solution

Intervention Type: DRUG

Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution

Interventions

Cardioplegia Solution

Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution

Intervention Type: DRUG

Other Intervention Names

Cardioplexol™

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cardio Technologies AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinik Innsbruck

Innsbruck, , Austria

Universitaetsklinikum Salzburg

Salzburg, , Austria

Universitaetsklnikum St. Pölten

Sankt Pölten, , Austria

Krankenhaus Hietzing

Vienna, , Austria

Deutsches Herzzentrum Berlin

Berlin, , Germany

Universitaetsklinikum Frankfurt

Frankfurt, , Germany

Countries

Austria; Germany

References

Tevaearai Stahel HT, Taheri N, Winkler A, Hohlfeld J, Dietl W, Starck C, Van Linden A, Bidovec J, Imhof A, Carrel TP, Voet B, Walther T, Seitelberger R, Grimm M, Holzinger C, Grabenwoger M. A multi-center, open label, single group, observational clinical trial to investigate the effects of training on the administration of Cardioplexol. Front Cardiovasc Med. 2025 May 26;12:1588088. doi: 10.3389/fcvm.2025.1588088. eCollection 2025.

Reference Type: DERIVED

PMID: 40491721 (View on PubMed)

Other Identifiers

SCT-Cpx-004

Identifier Type: -

Identifier Source: org_study_id