Heart DiseasePhase 4NCT00296985
Continuous Cellsaver and Neurocognitive Decline Post Cardiac Surgery
A Phase 4 study testing Fresenius Cellsaver in people with Heart Disease and Neurocognitive Decline, run by University Health Network, Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Disease, Neurocognitive Decline
- What is being tested?
- Fresenius Cellsaver
- Type of treatment
- Medical device
- How many people
- 312 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2001to Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 65 years,
- elective CABG surgery
- signed informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
About this study
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.
- Conditions
- Heart Disease, Neurocognitive Decline
- Being tested
- Fresenius Cellsaver
- Keywords
- Cardiac surgery, Cellsaver, Neurocognitive Function, Neuronal Protection, Quality of Life
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresenius CellsaverDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
A secondary aim is to determine if the improvement in cognitive function is associated with improved quality of life after cardiac surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startDec 2001
- Primary completionJan 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 312 participants
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Responsible party
- Sponsor
- Investigators
- George N Djaiani, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296985
- Sponsor's protocol ID
- UHN REB 01-0420-B
- Other IDs
- HSFO NA4915
- Status last verified
- Nov 2013
- First submitted
- 23 Feb 2006
- Last updated
- 27 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Continuous Flow Cellsaver on Neurocognitive Decline After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00296985
- Acronym / sponsor ID
- UHN REB 01-0420-B
- Conditions
- Heart Disease, Neurocognitive Decline
- Keywords
- Cardiac surgery, Cellsaver, Neurocognitive Function, Neuronal Protection, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Dec 2001
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 27 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 65 years,
- elective CABG surgery
- signed informed consent
Key exclusion criteria (6 listed)
- Severe kidney (creatinine > 2.5mg/dL and
- liver disease (bilirubin > 2 mg/dL)
- symptomatic cerebrovascular disease
- alcoholism
- psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresenius Cellsaver | Device | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
Related trials for Heart Disease
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George N Djaiani, MD principal investigator
Toronto General Hospital, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fresenius Cellsaver in people with Heart Disease and Neurocognitive Decline, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2013.