Ignite Creation Date:
2024-05-06 @ 1:59 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01941459
Status:
COMPLETED
Last Update Posted:
2013-09-13
First Post:
2012-05-07
Brief Title:
Comparison of Blood Cardioplegia and Custodiol
Sponsor:
Ullevaal University Hospital
Organization:
Oslo University Hospital
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:
None
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?:
None