Comparison of Blood Cardioplegia and Custodiol (NCT01941459)

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.

Read the detailed description

Objective: Myocardial protection during a cardiac arrest is mostly managed with cardioplegia. To day we normally used a blood or crystalloid based solutions. It has been published a lot of papers comparing the too groups with different results. To our knowledge no prospective, randomized study has compared modified St Thomas based Blood and Crystalloid cardioplegia on the acknowledged markers (CK-MB, troponin-T) of myocardial damage during aortic valve replacement on patients without additional significant coronary artery disease.

Methods: 100 patients with aorta stenoses undergoing aortic valve replacement without significant coronary artery stenoses or other significant concomitant heart valve disease were included in the study. They were given antegrade cold blood or cold crystalloid cardioplegia delivered through the coronary Ostia every 20 min throughout the period of aortic cross-clamp. CK-MB and troponin-T were compared between the two groups.

Published 2010 in the journal of thoracic and cardiovascular surgery.

Conditions studied

Mitral Insufficiencies
Myocardial Protection

Browse trials for

Mitral Valve Insufficiency 459

Keywords

CK-MB
troponin-T

In context

Mitral Valve Insufficiency

459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.

This study's enrollment of 76 is below the median of 154 across 167 observational studies indexed under Mitral Valve Insufficiency.

Browse Mitral Valve Insufficiency studies →

Lead sponsor

Ullevaal University Hospital is the lead sponsor of 76 studies on the registry; none are open to participants now.

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

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Between Mars 2007 and December 2009, 80 consecutive patients undergoing elective mitral valve surgery for mitral regurgitation at Oslo University Hospital Ullevål, Oslo, Norway and Sahlgrenska University Hospital, Gothenburg, Sweden were included in the study after informed written consent.

Eligibility criteria

The study protocol was approved by the local ethical committees. Eligible for operation were:

Inclution Criteria

patients with mitral regurgitation equal to or larger than grade 3 out of 4.
Ablation for atrial fibrillation was the only concomitant procedure that was allowed in addition to mitral valve surgery and these patients were block-randomized to ensure equally many patients with ablation in the two groups of cardioplegia.

Exclusion Criteria

Patients with any other concomitant heart valve disease or coronary artery stenoses (≥ 50%) were excluded from the study.
Age below 18
Pregnant

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 76 participants (actual)
Patient registry: No

Groups and cohorts

1 Custodiol
Custodiol
2 Blood cardioplegia
Blood cardioplegia

What researchers measure

Primary outcomes

CK-MB ,troponin-T
Time frame: 72 hours

Study locations

1 site

thoraxkirurgisk avd, UUS
Oslo, Norway

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01941459
Lead sponsor: Ullevaal University Hospital
Responsible party: Bjørn Braathen (MD. Ph.D, Oslo University Hospital) — Principal investigator
First posted: Sep 13, 2013
Start date: Mar 2007
Primary completion: Dec 2009
Completion: Jan 2010
Last update: Sep 13, 2013

Study contacts

Theis Tønnessen, prof.dr.med

study director · Thoraxkirurgisk avd. UUS

Bjørn Braathen, med.doc

study chair · Thoraxkir.avd. UUS

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Comparison of Blood Cardioplegia and Custodiol