Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-02-20 @ 3:44 PM
Study NCT ID:
NCT01941459
Status:
COMPLETED
Last Update Posted:
2013-09-13
First Post:
2012-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Blood Cardioplegia and Custodiol
Sponsor:
Ullevaal University Hospital
Organization:
Study Overview
Official Title:
Comparison of Blood Cardioplegia and Custodiol on Patients Operated for Significant Mitral Valve Innsufisiens. An Prospective, Randomized Two-center Study.
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: