CClinicalTrials.gg
CompletedNCT00257777Updated Jul 6, 2011

Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

An interventional study of Myocardial protection techniques in Aortic Valve Disease and Coronary Artery Disease, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Per ClinicalTrials.gov, last updated 2011-07-06.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
350
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Aortic Valve Disease
  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 350 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Aortic valve replacement

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
350 participants (estimated)

Interventions

  • ProcedureMyocardial protection techniques
06

What researchers measure

Primary outcomes

  1. Myocardial function,

  2. postoperative ventilatory support, postoperative arrhythmia,

  3. blood transfusions,

  4. physical recovery,

  5. mortality.

Secondary outcomes

  1. Costs

07

Study locations

1 site
  • RRHF
    Oslo, 0027, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00257777
Lead sponsor
Oslo University Hospital
First posted
Nov 23, 2005
Start date
Nov 2003
Primary completion
Nov 2007
Completion
Nov 2007
Last update
Jul 6, 2011

Study contacts

Eivind Øvrum, MD,PhD
principal investigator · Oslo University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2005. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion