Ignite Creation Date:
2024-05-06 @ 2:00 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01941420
Status:
COMPLETED
Last Update Posted:
2013-09-13
First Post:
2012-05-07
Brief Title:
Comparison of Blood and Crystalloid Cardioplegia
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Comparison of Blood and Crystalloid Cardioplegia on Patients Operated With Significant Aortic Stenosis A Prospective Randomized 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:
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 This group of patients was chosen for two reasons First these patients have left ventricular hypertrophy making the myocardium vulnerable to ischemia secondly the investigators wanted to avoid the possible confounding effect of ischemia found in patients with variable degrees of coronary artery disease Therefore patients with additional significant coronary artery disease 50 stenoses were excluded from the study
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
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
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