Continuous Cellsaver and Neurocognitive Decline Post Cardiac Surgery
NCT ID: NCT00296985
Last Updated: 2013-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
312 participants
INTERVENTIONAL
2001-12-31
2007-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Interventions
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Fresenius Cellsaver
Eligibility Criteria
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Inclusion Criteria
* elective CABG surgery
* signed informed consent
Exclusion Criteria
* liver disease (bilirubin \> 2 mg/dL)
* symptomatic cerebrovascular disease
* alcoholism
* psychiatric illness
* patients who are unable to read or who have less than a 7th grade education.
60 Years
ALL
No
Sponsors
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Heart and Stroke Foundation of Ontario
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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George N Djaiani, MD
Role: PRINCIPAL_INVESTIGATOR
Toronto General Hospital, University Health Network
Locations
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Toronto General Hospital, University Health Network
Toronto, Ontario, Canada
Countries
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Other Identifiers
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HSFO NA4915
Identifier Type: -
Identifier Source: secondary_id
UHN REB 01-0420-B
Identifier Type: -
Identifier Source: org_study_id