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Continuous Cellsaver and Neurocognitive Decline Post Cardiac Surgery

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00296985
First received: February 23, 2006
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Heart Disease
Neurocognitive Decline
Device: Fresenius Cellsaver
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: The Impact of Continuous Flow Cellsaver on Neurocognitive Decline After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 preoperative and postoperative psychometric and neurologic testing. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A secondary aim is to determine if the improvement in cognitive function is associated with improved quality of life after cardiac surgery. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 312
Study Start Date: December 2001
Study Completion Date: January 2007
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 65 years,
  • elective CABG surgery
  • signed informed consent

Exclusion Criteria:

  • Severe kidney (creatinine > 2.5mg/dL and
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296985

Locations
Canada, Ontario
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: George N Djaiani, MD Toronto General Hospital, University Health Network
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00296985     History of Changes
Other Study ID Numbers: UHN REB 01-0420-B, HSFO NA4915
Study First Received: February 23, 2006
Last Updated: November 25, 2013
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Cardiac surgery
Cellsaver
Neurocognitive Function
Neuronal Protection
Quality of Life

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014