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Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial

This study has been completed.
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:
NCT00059319
First received: April 23, 2003
Last updated: May 18, 2007
Last verified: May 2007

April 23, 2003
May 18, 2007
January 1999
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Complete list of historical versions of study NCT00059319 on ClinicalTrials.gov Archive Site
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Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial
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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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Coronary Disease
  • Procedure: single aorta clamp with retrograde cardioplegia
  • Procedure: multiple aorta clamps with antegrade cardioplegia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
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  • 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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00059319
R01NS37242
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National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: John W. Hammon, M.D. Wake Forest School of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP