A multi-center, open label, single group, observational study to investigate the effects of training on the administration of Cardioplexol (TM)?

Phase 1

• Conditions: Medical conditions with the need for an elective surgical coronary artery bypass grafting (CABG) and/or a valve repair/replacement .; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-002311-10-AT
• Lead Sponsor: Swiss Cardio Technologies AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-24
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

1. Male or female patients between 18 and 80 years of age;
2. The patient’s preoperative evaluation indicates the need for a primary elective cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve repair/replacement;
3. The operation will be carried out via a full or a hemi sternotomy, under cardiac arrest and under the assistance of a heart lung machine;
4. Patients who provide signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105

Exclusion Criteria

1. Pre-operative EF of less than 30%;
2. Pre-operative IABP;
3. Pre-operative catecholamine support;
4. History of myocardial infarction within less than 7 days;
5. Previous history of cardiac surgery, including the implantation of a pace maker or an ICD;
6. Active myocarditis and/or endocarditis;
7. Aortic valve insufficiency severity grade > 1;
8. Under dialysis;
9. Pre-operative serum creatinine value of more than 2.0 mg/dl;
10. Known hematologic disorder;
11. Previous therapeutic treatment with anti-vitamin K within 5 days before surgery, or with thrombin inhibitors or factor Xa Inhibitors within 3 days before surgery;
12. History of HIT;
13. Participating in a concomitant research study of an investigational product;
14. Pregnant or lactating;
15. Intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified