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Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00257777
First received: November 22, 2005
Last updated: July 3, 2011
Last verified: November 2005
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

Resource links provided by NLM:

U.S. FDA Resources

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Aortic valve replacement

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257777

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

No publications provided

ClinicalTrials.gov Identifier: NCT00257777     History of Changes
Other Study ID Numbers: AVR03, AVR03
Study First Received: November 22, 2005
Last Updated: July 3, 2011
Health Authority: Norway: Norwegian Medicines Agency
Norway:The Data Inspectorate Norway
Norway: Directorate of Health

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

ClinicalTrials.gov processed this record on May 16, 2013