Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059319
Status:
COMPLETED
Last Update Posted:
2007-05-21
First Post:
2003-04-23
Brief Title:
Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institute of Neurological Disorders and Stroke NINDS
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-05
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 purpose of this trial is to determine whether aortic manipulation in patients undergoing coronary bypass graft surgery leads to increased incidence of microemboli and subsequent impairment of neurobehavioral function
Detailed Description:
Patients who have coronary artery bypass graft CABG surgery must have their aorta the large blood vessel that is attached to the heart clamped with an instrument There are two basic ways of manipulating the aorta during surgery One way is to place a single clamp across the aorta The other way is to place more than one clamp on the aorta in several places Both methods are used but it is not known if one way is better than the other
The purpose of this study is to compare the two methods of clamping to see if one way is better than the other and to determine whether patients who undergo reduced manipulation of the aorta have fewer microemboli delivered to the brain during CABG surgery and have a lower incidence of neurobehavioral problems following surgery Microemboli are tiny fat particles that enter the bloodstream during surgery circulate to the brain and block tiny blood vessels causing brain deficits
Participants in this trial will be randomly classified into one of two groups the experimental group will undergo cross clamping of the aorta with a single clamp and be given retrograde cardioplegia for heart protection and the control group will undergo cross clamping of the aorta with multiple clamps and be given antegrade cardioplegia for heart protection Neurobehavioral assessments will be accomplished with a comprehensive battery of neurological and neuropsychological tests
The purpose of this study is to compare the two methods of clamping to see if one way is better than the other and to determine whether patients who undergo reduced manipulation of the aorta have fewer microemboli delivered to the brain during CABG surgery and have a lower incidence of neurobehavioral problems following surgery Microemboli are tiny fat particles that enter the bloodstream during surgery circulate to the brain and block tiny blood vessels causing brain deficits
Participants in this trial will be randomly classified into one of two groups the experimental group will undergo cross clamping of the aorta with a single clamp and be given retrograde cardioplegia for heart protection and the control group will undergo cross clamping of the aorta with multiple clamps and be given antegrade cardioplegia for heart protection Neurobehavioral assessments will be accomplished with a comprehensive battery of neurological and neuropsychological tests
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: