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

NCT03823521 | Completed Phase 3

• 1 other identifier: SCT-Cpx-004
• Study Type: interventional
• Target: 171
• Locations: 2 countries
• Sites: 6

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

Keywords

Cardioplegic Solutions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• TnT Values

  During the first 24 hours following myocardial reperfusion

• CK-MB Values

  During the first 24 hours following myocardial reperfusion

• Complete Cardiac Arrest

  During Surgery

• Catecholamine

  During during aortic cross-clamping and during the first 24 hours

• Defibrillation rate

  During surgery

Study Arms (1)

Cardioplexol™- Cardioplegia Solution

EXPERIMENTAL

Cardioplexol™ will be used as cardioplegic solution in cardiac surgery

Drug: Cardioplegia Solution

Interventions

Cardioplegia Solution DRUG

Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution

Also known as: Cardioplexol™

Cardioplexol™- Cardioplegia Solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Cardio Technologies AG: lead

Study Sites (6)

Universitätsklinik Innsbruck

Innsbruck, 6020, Austria

Location

Universitaetsklinikum Salzburg

Salzburg, 5020, Austria

Location

Universitaetsklnikum St. Pölten

Sankt Pölten, 3100, Austria

Location

Krankenhaus Hietzing

Vienna, 1130, Austria

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Universitaetsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Related Publications (1)

• 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.

  PMID: 40491721 DERIVED

MeSH Terms

Interventions

Cardioplegic Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: January 30, 2019
• Study Start: November 20, 2018
• Primary Completion: October 18, 2021
• Study Completion: October 18, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

DE (2); AU (4)