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Comparison of Blood Cardioplegia and Custodiol

NCT01941459 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 76

Last updated 2013-09-13

No results posted yet for this study

Summary

Thru the last 20 years it has been a discussion witch solution that gives the best myocardial protection during cardiac arrest by heart operations.

* It has been a tendency that a blood based cardioplegia gives a better protection bye long ischemic times but it has not been possible too conclude in this matter.
* The investigators have two groups of cardioplegia, the blood based and, the crystalloid based cardioplegia.
* It has been done a lot of studies to see what kind of cardioplegia that gives the best myocardial protection. Different temperature, different amount and content, retrograde or antegrade or both, contentiously and further on have been tested without a clear conclusion.
* The investigators decided to make a study with a cohort of patients as homogenous as possible with a cross clamp time around 70 min.
* Adult patients' with a severe aortic stenoses without any other significant heart disease was included in our prospective randomised study.
* Patients with additional significant coronary artery disease (≥ 50% stenoses) were excluded from the study.
* The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the myocardial damage.

Conditions

  • Mitral Insufficiencies
  • Myocardial Protection

Sponsors & Collaborators

  • Ullevaal University Hospital

    lead OTHER

Principal Investigators

  • Theis Tønnessen, prof.dr.med · Thoraxkirurgisk avd. UUS

  • Bjørn Braathen, med.doc · Thoraxkir.avd. UUS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-12-31
Completion
2010-01-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01941459 on ClinicalTrials.gov