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Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00257777
Enrollment
350
Registered
2005-11-23
Start date
2003-11-30
Completion date
2007-11-30
Last updated
2011-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Coronary Artery Disease

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

Interventions

PROCEDUREMyocardial protection techniques

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Aortic valve replacement

Design outcomes

Primary

MeasureTime frame
Myocardial function,
postoperative ventilatory support, postoperative arrhythmia,
blood transfusions,
physical recovery,
mortality.

Secondary

MeasureTime frame
Costs

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026