Phase III Study Comparing Two Methods of Cardioplegia in... | NCT02098772

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

NCT02098772

Sponsor

Dr. F. Köhler Chemie GmbH

Status

Completed

Last Update Posted

Jan 18, 2020Actual

Enrollment

530Actual

Phase

Phase 3

Conditions

Aortic Valve Disease
Coronary Artery Disease (CAD)

Interventions

Custodiol-N
Custodiol

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014Actual

Primary Completion Date

Nov 16, 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Feb 14, 2014

First Submission Date that Met QC Criteria

Mar 25, 2014

First Posted Date

Mar 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2020

Last Update Posted Date

Jan 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 (e.g., myocardial infarction).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

530Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Custodiol-N	Experimental	comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery	Drug: Custodiol-N
Custodiol	Active Comparator	comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery	Drug: Custodiol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Custodiol-N	Drug	comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery	Custodiol-N

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
peak value for CK-MB		measured at 4, 8, 12, 16, 20 and 24 hours after the release of the aortic cross clamp

Secondary Outcomes

Measure	Description	Time Frame
Catecholamine requirement on SICU		within 24 hours (cumulative dose)

Other Outcomes

Measure	Description	Time Frame
Safety parameters	documentation and reporting of AE and SAE	from time of the study inclusion up to the follow-up visit on day 5

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients >/= 30 and \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabor Szabó, Prof.	Department of Cardiac Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Herzchirurgie, Universitätsklinikum Heidelberg		Heidelberg	Baden-Wurttemberg	69120	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000082862	Aortic Valve Disease
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003327	Coronary Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C549285	Custodiol-N solution

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided