Back to resultsIntermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery
Primary Purpose
Aortic Valve Disease, Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Myocardial protection techniques
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Disease
Eligibility Criteria
Aortic valve replacement
Sites / Locations
- RRHF
Outcomes
Primary Outcome Measures
Myocardial function,
postoperative ventilatory support, postoperative arrhythmia,
blood transfusions,
physical recovery,
mortality.
Secondary Outcome Measures
Costs
Full Information
NCT ID
NCT00257777
First Posted
November 22, 2005
Last Updated
July 3, 2011
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00257777
Brief Title
Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery
Official Title
Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oslo University Hospital
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease, Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Myocardial protection techniques
Primary Outcome Measure Information:
Title
Myocardial function,
Title
postoperative ventilatory support, postoperative arrhythmia,
Title
blood transfusions,
Title
physical recovery,
Title
mortality.
Secondary Outcome Measure Information:
Title
Costs
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Aortic valve replacement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eivind Øvrum, MD,PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
RRHF
City
Oslo
ZIP/Postal Code
0027
Country
Norway
12. IPD Sharing Statement
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Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery
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