Status:
COMPLETED
Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™
Lead Sponsor:
Swiss Cardio Technologies AG
Conditions:
Coronary Artery Bypass Surgery
Valve Surgery
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2021
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT03823521
Start Date
November 20 2018
End Date
October 18 2021
Last Update
October 21 2021
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinik Innsbruck
Innsbruck, Austria, 6020
2
Universitaetsklinikum Salzburg
Salzburg, Austria, 5020
3
Universitaetsklnikum St. Pölten
Sankt Pölten, Austria, 3100
4
Krankenhaus Hietzing
Vienna, Austria, 1130