Comparison of two cardiac protection techniques during cardiac surgery

A Single-Centre, Single Blind, Randomized, Active-Controlled Phase III Non-Inferiority Study to Investigate the Safety and Efficacy of the Cardioplegic Solution Cardioplexol? when used during a Cardiac Surgical Intervention under the Assistance of a Heart-Lung Machine

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004198-10-AT

Enrollment

240

Registered

2011-10-04

Start date

2012-03-22

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical conditions necessitating an elective surgical coronary artery bypass grafting (CABG) and/or a valve repair/replacement.

Interventions

Product Name: Cardioplexol Product Code: Cpx Pharmaceutical Form: Solution for injection/infusion CAS Number: 7447-40-7 Other descriptive name: POTASSIUM CHLORIDE Concentration unit: mg milligram(s) C

Eligibility

Sex/Gender

All

Inclusion criteria

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 can be carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine; 4. Patients (or legal representatives) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. pre-operative EF of less than 30%; 2. pre-operative IABP; 3. under 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. history of atrial fibrillation; 8. aortic valve insufficiency severity grade > 1; 9. history of neurologic event; 10. carotid artery disease; 11. renal insufficiency or is under dialysis; 12. pre-operative serum creatinine value of more than 2.0 mg/dl; 13. known for an hematologic disorder; 14. under anti-vitamin K; 15. history of HIT; 16. participating in a concomitant research study of an investigational product; 17. pregnant or lactating; 18. intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent;

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Maximal value of troponin-T (ng/ml) during the first 24 hours following myocardial reperfusion.;Timepoint(s) of evaluation of this end point: During the first 24 hours post-reperfusion ;Main Objective: To explore the effects of CardioplexolTM on the protection of cardiac cells during the “ischemic” period in order to allow a rapid and complete reversibility of the cardiac arrest when used during a cardiac surgical intervention under the assistance of a heart-lung machine.;Secondary Objective: - To explore the effects on duration in ICU stay and on duration of hospitalisation - To evaluate the safety and tolerability of CardioplexolTM	—

Measure

Time frame

Primary end point(s): Maximal value of troponin-T (ng/ml) during the first 24 hours following myocardial reperfusion.;Timepoint(s) of evaluation of this end point: During the first 24 hours post-reperfusion ;Main Objective: To explore the effects of CardioplexolTM on the protection of cardiac cells during the “ischemic” period in order to allow a rapid and complete reversibility of the cardiac arrest when used during a cardiac surgical intervention under the assistance of a heart-lung machine.;Secondary Objective: - To explore the effects on duration in ICU stay and on duration of hospitalisation - To evaluate the safety and tolerability of CardioplexolTM

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Secondary

Measure	Time frame
Secondary end point(s): 1. Maximal value of CK-MB during the first 24 hours following myocardial reperfusion. 2. Time between the aortic cross-clamping and the complete cardiac arrest. 3. Percentage of patients requiring catecholamines during aortic cross-clamping. 4. Cumulative dose of catecholamines during aortic cross-clamping. 5. Defibrillation rate after aorta unclamping and coronary reperfusion. 6. Cumulative dose of catecholamines during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). 7. Percentage of patients requiring the installation of an IABP during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). 8. Duration of intubation. 9. Duration of ICU stay. 10. Mortality during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). 11. Maximal ST elevation during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). 12. Duration of hospitalization. Safety Endpoints: 1.Serious and non-serious adverse events. 2.Vital signs 3.Clinical laboratory data (haematology and blood chemistry). 4.12-lead electrocardiogram (ECG). ;Timepoint(s) of evaluation of this end point: During the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). Safety is evaluated up to 30 days after the end of the surgery.	—

Measure

Time frame

Secondary end point(s): 1. Maximal value of CK-MB during the first 24 hours following myocardial reperfusion. 2. Time between the aortic cross-clamping and the complete cardiac arrest. 3. Percentage of patients requiring catecholamines during aortic cross-clamping. 4. Cumulative dose of catecholamines during aortic cross-clamping. 5. Defibrillation rate after aorta unclamping and coronary reperfusion. 6. Cumulative dose of catecholamines during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). 7. Percentage of patients requiring the installation of an IABP during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). 8. Duration of intubation. 9. Duration of ICU stay. 10. Mortality during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). 11. Maximal ST elevation during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). 12. Duration of hospitalization. Safety Endpoints: 1.Serious and non-serious adverse events. 2.Vital signs 3.Clinical laboratory data (haematology and blood chemistry). 4.12-lead electrocardiogram (ECG). ;Timepoint(s) of evaluation of this end point: During the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). Safety is evaluated up to 30 days after the end of the surgery.

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Countries

Austria

Contacts

Public ContactHendrik Tevaearai

Swiss Cardio Technologies AG

hendrik.tevaearai@swisscardiotech.com41316322373

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026