Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial

Patrocinadores

Patrocinador principal: National Institute of Neurological Disorders and Stroke (NINDS)

Fuente National Institute of Neurological Disorders and Stroke (NINDS)
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio January 1999
Fase Phase 3
Tipo de estudio Interventional
Inscripción 300
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: single aorta clamp with retrograde cardioplegia

Tipo de intervención: Procedure

Nombre de intervención: multiple aorta clamps with antegrade cardioplegia

Elegibilidad

Criterios:

- 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.

Género: All

Edad mínima: 50 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
John W. Hammon, M.D. Principal Investigator Wake Forest University Health Sciences
Ubicación
Instalaciones: Wake Forest University Baptist Medical Center
Ubicacion Paises

United States

Fecha de verificación

May 2007

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Propósito primario: Treatment

Fuente: ClinicalTrials.gov