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OpenTrials
Completed

NCT Number: NCT00257777

Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

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.

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Key information

Conditions

Aortic Valve Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RRHF

Oslo, 0027, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Aortic valve replacement

Treatment and study plan

Myocardial protection techniques

Procedure

Primary outcomes

  1. Myocardial function,

  2. postoperative ventilatory support, postoperative arrhythmia,

  3. blood transfusions,

  4. physical recovery,

  5. mortality.

Secondary outcomes

  1. Costs

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Nov 23, 2005
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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