Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

Coronary Artery Disease Clinical Trial

Official title:

Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257777
• Other study ID #: AVR03
• Secondary ID: AVR03
• Status: Completed
• Phase: N/A
• First received: November 22, 2005
• Last updated: July 3, 2011
• Start date: November 2003
• Est. completion date: November 2007

Study information

• Verified date: November 2005
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway:The Data Inspectorate NorwayNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older
• Eligibility: Aortic valve replacement

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Disease
• Coronary Artery Disease
• Coronary Disease
• Heart Defects, Congenital
• Heart Valve Diseases
• Myocardial Ischemia

Intervention

Procedure:
• Myocardial protection techniques

Locations

Country	Name	City	State
Norway	RRHF	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial function,
Primary	postoperative ventilatory support, postoperative arrhythmia,
Primary	blood transfusions,
Primary	physical recovery,
Primary	mortality.
Secondary	Costs