NCT02098772

Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol

A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 530 (actual)
• Sponsor: Dr. F. Köhler Chemie GmbH · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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 (e.g., myocardial infarction).

Conditions

• Aortic Valve Disease
• Coronary Artery Disease (CAD)

Interventions

Type	Name	Description
DRUG	Custodiol-N	comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
DRUG	Custodiol	comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-11-16
• Completion: 2018-12-01
• First posted: 2014-03-28
• Last updated: 2020-01-18

Locations

6 sites across 1 country: Germany