We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00257777
First Posted: November 23, 2005
Last Update Posted: July 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oslo University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Aortic valve replacement
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00257777     History of Changes
Other Study ID Numbers: AVR03
First Submitted: November 22, 2005
First Posted: November 23, 2005
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