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Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

This study has been completed.
Information provided by:
Oslo University Hospital Identifier:
First received: November 22, 2005
Last updated: July 3, 2011
Last verified: November 2005
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 Intervention
Aortic Valve Disease
Coronary Artery Disease
Procedure: Myocardial protection techniques

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Myocardial function,
  • postoperative ventilatory support, postoperative arrhythmia,
  • blood transfusions,
  • physical recovery,
  • mortality.

Secondary Outcome Measures:
  • Costs

Estimated Enrollment: 350
Study Start Date: November 2003
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Aortic valve replacement
  Contacts and Locations
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Please refer to this study by its identifier: NCT00257777

Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Eivind Øvrum, MD,PhD Oslo University Hospital
  More Information Identifier: NCT00257777     History of Changes
Other Study ID Numbers: AVR03
Study First Received: November 22, 2005
Last Updated: July 3, 2011

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on April 28, 2017