Continuous Cellsaver and Neurocognitive Decline Post Cardiac Surgery

Heart Disease Clinical Trial

Official title:

The Impact of Continuous Flow Cellsaver on Neurocognitive Decline After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296985
• Other study ID #: UHN REB 01-0420-B
• Secondary ID: HSFO NA4915
• Status: Completed
• Phase: Phase 4
• First received: February 23, 2006
• Last updated: November 25, 2013
• Start date: December 2001
• Est. completion date: January 2007

Study information

• Verified date: November 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: January 2007
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Disease
• Neurocognitive Decline

Intervention

Device:
• Fresenius Cellsaver

Locations

Country	Name	City	State
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year	No
Secondary	A secondary aim is to determine if the improvement in cognitive function is associated with improved quality of life after cardiac surgery.		1 year	No