Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

NCT ID: NCT00257777

Last Updated: 2011-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2007-11-30

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

Conditions

Aortic Valve Disease; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Myocardial protection techniques

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Aortic valve replacement

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Eivind Øvrum, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

RRHF

Oslo, , Norway

Countries

Norway

Other Identifiers

AVR03

Identifier Type: -

Identifier Source: secondary_id

AVR03

Identifier Type: -

Identifier Source: org_study_id