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Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

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ClinicalTrials.gov Identifier: NCT00257777
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : July 6, 2011
Sponsor:
Information provided by:
Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Disease Coronary Artery Disease Procedure: Myocardial protection techniques Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery
Study Start Date : November 2003
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007



Primary Outcome Measures :
  1. Myocardial function,
  2. postoperative ventilatory support, postoperative arrhythmia,
  3. blood transfusions,
  4. physical recovery,
  5. mortality.

Secondary Outcome Measures :
  1. Costs


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Aortic valve replacement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257777


Locations
Norway
RRHF
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Eivind Øvrum, MD,PhD Oslo University Hospital

ClinicalTrials.gov Identifier: NCT00257777     History of Changes
Other Study ID Numbers: AVR03
AVR03
First Posted: November 23, 2005    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: November 2005

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases