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Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial

Primary Purpose

Coronary Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
single aorta clamp with retrograde cardioplegia
multiple aorta clamps with antegrade cardioplegia
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring coronary artery bypass graft surgery, CABG surgery, neurobehavioral impairment, aorta clamping, aorta manipulation, microemboli

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Participants must be English-speaking patients, 50 years of age or older, and undergoing elective CABG surgery. Participants of both genders and all races are eligible.

Sites / Locations

  • Wake Forest University Baptist Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 23, 2003
Last Updated
May 18, 2007
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00059319
Brief Title
Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
coronary artery bypass graft surgery, CABG surgery, neurobehavioral impairment, aorta clamping, aorta manipulation, microemboli

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
single aorta clamp with retrograde cardioplegia
Intervention Type
Procedure
Intervention Name(s)
multiple aorta clamps with antegrade cardioplegia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Participants must be English-speaking patients, 50 years of age or older, and undergoing elective CABG surgery. Participants of both genders and all races are eligible.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W. Hammon, M.D.
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Baptist Medical Center
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial

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