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Generated: February 23, 2019

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CLINICAL TRIALS PROFILE FOR CARDIOPLEGIC IN PLASTIC CONTAINER

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Clinical Trials for Cardioplegic In Plastic Container

Trial ID Title Status Sponsor Phase Summary
NCT00934596 CO2 Versus Lund De-airing Technique in Heart Surgery Completed Lund University N/A To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing technique) can shorten the left heart de-airing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the left heart to the ambient air. To evaluate the cost effectiveness and possible side effects of CO2 de-airing technique compared to Lund de-airing technique.
NCT01123525 Adenosine Cardioplegia; Improved Cardioprotection? Completed University Hospital of North Norway Phase 1/Phase 2 60 elective patients for CABG will be included to receive either standard hyperkalemic cardioplegia (St.Thomas Hospital Solution No I) or cardioplegia where supranormal potassium is replaced with 1.2 mM adenosine. Hypothesis as follows: 1. Adenosine instead of supranormal potassium in the cardioplegic solution give satisfactory cardiac arrest. 2. Adenosine instead of supranormal potassium in the cardioplegic solution gives equal cardioprotection. The patients will be followed with PiCCO-catheter to monitor cardiac function and repetitive blood samples to measure release of cardiac enzymes.
NCT01401140 Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis Completed Association AIRE (FR) Phase 3 An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue. High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.
NCT01401140 Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis Completed Jazz Pharmaceuticals Phase 3 An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue. High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.
NCT01401140 Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis Completed Centre Hospitalier Universitaire de Saint Etienne Phase 3 An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue. High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.
NCT01406678 Remote Ischemic Preconditioning in Coronary Artery Bypass Grafting With Cold Crystalloid Cardioplegic Arrest Recruiting University Hospital, Essen Phase 2/Phase 3 Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion reduces myocardial injury in patients undergoing on-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The present study assesses protection of heart, brain and kidney by RIPC under crystalloid cardioplegic arrest. The study also addresses safety and clinical outcome.
NCT01444235 Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery Completed Dr. F. Köhler Chemie GmbH Phase 2 Comparison of the cardioprotective effects and safety of two cardioplegic solutions (solutions used during a cardiac arrest in the heart surgery) in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Cardioplegic In Plastic Container

Condition Name

Condition Name for Cardioplegic In Plastic Container
Intervention Trials
Coronary Artery Disease (CAD) 2
Congenital Heart Disease 2
Cardiomyopathies 1
Coronary Artery Stenosis 1
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Condition MeSH

Condition MeSH for Cardioplegic In Plastic Container
Intervention Trials
Heart Diseases 4
Heart Defects, Congenital 3
Myocardial Ischemia 3
Coronary Disease 3
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Clinical Trial Locations for Cardioplegic In Plastic Container

Trials by Country

Trials by Country for Cardioplegic In Plastic Container
Location Trials
Germany 7
United States 2
Netherlands 1
Egypt 1
France 1
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Trials by US State

Trials by US State for Cardioplegic In Plastic Container
Location Trials
Texas 1
Michigan 1
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Clinical Trial Progress for Cardioplegic In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Cardioplegic In Plastic Container
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Cardioplegic In Plastic Container
Clinical Trial Phase Trials
Recruiting 6
Completed 5
Not yet recruiting 3
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Clinical Trial Sponsors for Cardioplegic In Plastic Container

Sponsor Name

Sponsor Name for Cardioplegic In Plastic Container
Sponsor Trials
Dr. F. Köhler Chemie GmbH 2
Mai Madkour 1
University Hospital, Essen 1
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Sponsor Type

Sponsor Type for Cardioplegic In Plastic Container
Sponsor Trials
Other 16
Industry 4
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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Chubb
Covington
US Army
Queensland Health
Citi
Colorcon
Accenture
Fish and Richardson

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