NCT00257777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

July 6, 2011

Status Verified

November 1, 2005

Enrollment Period

4 years

First QC Date

November 22, 2005

Last Update Submit

July 3, 2011

Conditions

Aortic Valve DiseaseCoronary Artery Disease

Outcome Measures

Primary Outcomes (5)

  • Myocardial function,

  • postoperative ventilatory support, postoperative arrhythmia,

  • blood transfusions,

  • physical recovery,

  • mortality.

Secondary Outcomes (1)

  • Costs

Interventions

Myocardial protection techniquesPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Aortic valve replacement

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

RRHF

Oslo, 0027, Norway

Location

MeSH Terms

Conditions

Aortic Valve DiseaseCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Eivind Øvrum, MD,PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2005

First Posted

November 23, 2005

Study Start

November 1, 2003

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

July 6, 2011

Record last verified: 2005-11

Locations

NO(1)