Viewing Study NCT02098772



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Study NCT ID: NCT02098772
Status: COMPLETED
Last Update Posted: 2020-01-18
First Post: 2014-02-14

Brief Title: Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
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 Aortic Valve Surgery Custodiol-N Versus Custodiol
Status: COMPLETED
Status Verified Date: 2018-02
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: Custodiol-AV
Brief Summary: 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 aortic valve surgery The study design is a prospective double blind multicenter randomized Phase III comparison study intended to demonstrate superiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24 hours after opening of the aortic cross-clamp primary endpoint catecholamine requirement cumulative dose and cardiac Troponin T occurrence of comorbid events postoperatively eg myocardial infarction
Detailed Description: None

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