Heart Disease Clinical Trial
Official title:
The Impact of Continuous Flow Cellsaver on Neurocognitive Decline After Cardiac Surgery
Patients having cardiac surgery to correct their heart disease may suffer a decline in
mental and neurologic abilities. Passage of small particles of fat, tissue waste and air
bubbles to the brain while on the heart-lung machine is thought to be one cause for decline
in mental and neurologic abilities (the function of brain) after surgery.
The purpose of this study is to determine if replacement of cardiotomy suction (one part of
the heart-lung machine) with the cell-saver (a different part of the heart-lung machine)
during surgery will help to prevent a decline in mental and neurologic abilities after
surgery. investigating 312 patients over 2 years,patients will be assigned randomly to
either cardiotomy suction or cell-saver group. Patients will be given questionnaires before
surgery, 6 weeks and 1-year after surgery. These questionnaires will assess memory,
attention span, the ability to concentrate and the quality of life. Patients will also have
a brief neurologic exam (physical examination to check mental state, reflexes, strength, and
balance) before surgery, 3-5 days after surgery, 6 weeks and 1-year after surgery to
determine any changes. Cell-saver separates red blood cells from tissue waste products and
fat prior to returning blood back to the patient and may reduce the negative effects of
particles of fat, tissue waste and air bubbles have on the brain. Potential benefits of
cell-saver device when used during surgery may prevent the decrease in memory, attention
span, and the ability to concentrate resulting in improved quality of life after surgery.
Objectives: The primary aim is to determine the effect of continuous flow cell-saver on
short and long term neurocognitive function after cardiac surgery, measured by precise
preoperative and postoperative psychometric and neurologic testing. Hypothesis: The primary
hypothesis: Continuous flow cell-saver reduces postoperative neurocognitive decline
following cardiac surgery. Methodology: 312 informed and consenting patients, age > 65
years, scheduled for coronary artery bypass graft surgery will be prospectively enrolled
over a 2-year period. Patients will be randomly allocated to either the continuous flow
cell-saver or conventional cardiotomy suction (controls). Neurological history and physical
exam will be completed preoperatively, discharge, 6-weeks and 1-year after surgery.
Transcranial Doppler scanning will be used for intraoperative monitoring of cerebral embolic
load. Transesophageal echocardiography and epiaortic scanning will be employed to account
for the severity of the aortic atheroma scores. Neurocognitive testing and quality of life
assessment will be conducted preoperatively , 6-weeks and 1-year after surgery.
Significance: The utilization of continuous flow cell-saver may reduce the negative effects
of fat particles, tissue waste and air emboli have on brain.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
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