Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

Not Applicable

Completed

• Conditions: Aortic Valve Disease; Coronary Artery Disease

• Registration Number: NCT00257777
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-11
• Status Verified: 2005-11
• Study First Submitted: 2005-11-22
• Study First Submitted QC: 2005-11-22
• Study First Posted: 2005-11-23
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Last Update Submitted: 2011-07-03
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Myocardial function,
postoperative ventilatory support, postoperative arrhythmia,
blood transfusions,
physical recovery,
mortality.

Secondary Outcome Measures

Name	Time	Method
Costs

Trial Locations

Locations (1)

RRHF; 🇳🇴 Oslo, Norway