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Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00059319
Enrollment
300
Registered
2003-04-24
Start date
1999-01-31
Completion date
Unknown
Last updated
2007-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease

Keywords

coronary artery bypass graft surgery, CABG surgery, neurobehavioral impairment, aorta clamping, aorta manipulation, microemboli

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.

Interventions

PROCEDUREsingle aorta clamp with retrograde cardioplegia
PROCEDUREmultiple aorta clamps with antegrade cardioplegia

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026