Intermittent Cold Blood vs Crystalloid Cardioplegia in Ao... | NCT00257777

Studies
Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

NCT00257777

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Jul 6, 2011Estimated

Enrollment

350Estimated

Phase

Not Applicable

Conditions

Aortic Valve Disease
Coronary Artery Disease

Interventions

Myocardial protection techniques

Countries

Norway

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

ID	Type	Description	Link
AVR03

Status Module

Record Verification Date

Nov 2005

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

Nov 2003

Primary Completion Date

Nov 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Nov 22, 2005

First Submission Date that Met QC Criteria

Nov 22, 2005

First Posted Date

Nov 23, 2005Estimated

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

Jul 3, 2011

Last Update Posted Date

Jul 6, 2011Estimated

Description Module

Brief Summary

Controversies still exists concerning the overall clinical effects of blood-based vs. crystalloid- based cardioplegic solution for myocardial protection during cardiac arrest. Both techniques are used world-wide. No larger prospectively randomized studies comparing the two methods have been reported. The aim of this study is to collect a large number of clinical data to create a proper basis for evaluation of the two techniques.

Detailed Description

All patients admitted for aortic valve replacement with or without concomitant CABG and operated by E.Ø. or G.T. are included in the study. All preoperative, operative and postoperative data are prospectively recorded, focusing on clinical outcome parameters

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Name	Type	Description	Arm Group Labels	Other Names
Myocardial protection techniques	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Myocardial function,
postoperative ventilatory support, postoperative arrhythmia,
blood transfusions,
physical recovery,
mortality.

Secondary Outcomes

Measure	Description	Time Frame
Costs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Aortic valve replacement

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eivind Øvrum, MD,PhD	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RRHF		Oslo		0027	Norway

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