Ignite Creation Date:
2024-05-05 @ 11:55 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01444235
Status:
COMPLETED
Last Update Posted:
2013-05-17
First Post:
2011-09-29
Brief Title:
Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery
Sponsor:
Dr F Köhler Chemie GmbH
Organization:
Dr F Köhler Chemie GmbH
Study Overview
Official Title:
A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery Custodiol-N Versus Custodiol
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions HTK Cardioplegic Solution Custodiol and Custodiol-N in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery The study design is a prospective double blind multicenter randomized Phase III comparison study intended to demonstrate non-inferiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB area under the curve primary endpoint catecholamine requirementcumulative dose and cardiac Troponin T occurrence of comorbid events postoperatively eg myocardial infarction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None