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Cardioplegia

Phase 3

Coronary Artery Bypass Surgery | Small molecule | Cardiovascular |Cardio Diagnostics Holdings Inc.|Last Updated: Oct 21, 2021

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment171
FDA Designations
No designations recorded
Clinical trial landscape

Cardioplegia · 1 trial · 2 indications

Phase 3 1
NCT03823521Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™Coronary Artery Bypass Surgery
COMPLETED171 Analytics
PHASE3COMPLETED
Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™
Coronary Artery Bypass Surgery
NCT03823521171
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Study Endpoints
Primary Endpoints
Major Deviation in Cardioplexol application
During surgery

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).

Secondary Endpoints
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
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Cardioplexol™- Cardioplegia SolutionEXPERIMENTALCardioplexol™ will be used as cardioplegic solution in cardiac surgery
Interventions
NameTypeDescription
Cardioplegia SolutionDRUGCardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution
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Eligibility Criteria
Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * 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 ...

Countries:AustriaGermany
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