Complication of Coronary Artery Bypass GraftNCT02554305
The Fusion Versus The Affinity Oxygenation Systems
A study testing fusion oxygenation system and Affinity oxygenation system in people with Complication of Coronary Artery Bypass Graft, run by Hadassah Medical Organization.
Trial summary
This study compares between the clinical, hematological, inflammatory and neurological outcome of patients undergoing Coronary Artery Bypass Grafting (CABG) surgery in which different oxygenation systems will be used. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Complication of Coronary Artery Bypass Graft
- What is being tested?
- fusion oxygenation system and Affinity oxygenation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2018
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18-75 years old) undergoing first-time, isolated CABG at the Hebrew University, Hadassah Medical Center, Jerusalem, Israel and the University Hospital of Angers, Angers, France.
- Patients undergoing elective peripheral vascular surgical procedures under general anesthesia
- Patients undergoing elective percutaneous coronary intervention will serve as control groups
Who cannot join
- Emergency operations
- Left ventricular ejection fraction less than 30%
- CABG with concomitant procedure
- Previous stroke or documented neurological disorder
- High grade (>70%) unilateral or bilateral carotid stenosis
- Contraindication to MRI testing.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Fusion Versus The Affinity Oxygenation Systems - A Prospective Randomized Trial In Patients Undergoing Coronary Artery Bypass Grafting (CABG)
This study compares between the clinical, hematological, inflammatory and neurological outcome of patients undergoing Coronary Artery Bypass Grafting (CABG) surgery in which different oxygenation systems will be used.
Read the detailed description
In order to assess the efficacy and safety of fusion Oxygenation System in patients undergoing isolated CABG, a prospective one-to-one randomized trial comparing the fusion oxygenation to the currently used affinity oxygenation system will be conducted. Forty patients intending to undergo CABG will be divided into 2 groups according to the oxygenation system which will be used during surgery. Distribution into groups will be done randomly. Ten patients undergoing elective peripheral vascular surgical procedures under general anesthesia and 10 patients undergoing elective percutaneous coronary intervention will serve as control groups for the neurological outcomes. Clinical status, inflammatory and hematological response as well as Neurological outcome will be assessed.
- Being tested
- fusion oxygenation system, Affinity oxygenation system
- Keywords
- efficacy and safety of fusion Oxygenation System, isolated Coronary Artery Bypass Grafting, Bypass Grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fusion oxygenation systemDevice
The fusion oxygenation system is a novel design of the pump oxygenator used in cardiopulmonary bypass, integrating multiple new engineering concepts that have altered its performance profile.
Affinity oxygenation systemDevice
The affinity oxygenation system is the classical pump oxygenator used in cardiopulmonary bypass surgeries
| Study group | Role | What they receive |
|---|---|---|
| Fusion oxygenation system | Active comparator | Fusion oxygenation machine will be used during the operation. Receives: Device: fusion oxygenation system |
| Affinity oxygenation system | Active comparator | Affinity oxygenation machine will be used during the operation. Receives: Device: Affinity oxygenation system |
| Peripheral vascular procedure | No intervention | No oxygenation machine will be used in this group |
| percutaneous coronary intervention | No intervention | No oxygenation machine will be used in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse events
Number of major adverse events (including mortality) will be assessed
Measured: Participants will be followed for 30 days following the surgery
Secondary outcomes (5)
Systemic inflammatory response
Serum markers of inflammation will be measured at 4 time points: after induction of anesthesia, immediately after termination of cardiopulmonary bypass, 3 hours, and 3 days postoperatively. : heparinized arterial (intraoperatively) or venous (postoperatively) blood samples will be collected. Bio-assay of endothelial permeability will be also done. Within each group, the change overtime will be compared to baseline. Participants' number with abnormal laboratory values in each study group will be assessed and compared with the other groups.
Measured: Participants will be followed 3 days following the surgery.
Number of participants with abnormal laboratory values
Hemoglobin and hematocrit, Platelet number and activation and Thrombin activation will be measured. Within each group, the change overtime will be compared to baseline. Participants' number with abnormal laboratory values in each study group will be assessed and compared with the other groups.
Measured: Participants will be followed for 3 days following the surgery.
Neurological outcomes-Functional magnetic resonance imaging (MRI)
Changes in brain structure and patterns of neural activation in response to cognitive tasks will be assessed using structural and functional MRI and compared between the study groups.
Measured: Changes in brain activity pattern will be assessed at baseline and 4 weeks postoperatively .
Neurological outcomes-Transcranial Doppler (TCD)
Changes in brain activity pattern before and after the surgery will be assessed and compared between the study groups.
Measured: Participants will be followed 3 days following the surgery.
Neurological outcomes- electroencephalogram (EEG)
Changes in brain activity pattern before and after the surgery will be assessed and compared between the study groups.
Measured: Participants will be followed 3 days following the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oz Shapira, Hadassah Medical Organization
- Investigators
- Oz Shapira, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554305
- Sponsor's protocol ID
- 0033-15-HMO
- Status last verified
- Sep 2015
- First submitted
- 9 Aug 2015
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fusion Versus The Affinity Oxygenation Systems - A Prospective Randomized Trial In Patients Undergoing Coronary Artery Bypass Grafting (CABG)
- ClinicalTrials.gov ID
- NCT02554305
- Acronym / sponsor ID
- 0033-15-HMO
- Keywords
- efficacy and safety of fusion Oxygenation System, isolated Coronary Artery Bypass Grafting, Bypass Grafting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 18 Sep 2015 (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.
This study compares between the clinical, hematological, inflammatory and neurological outcome of patients undergoing Coronary Artery Bypass Grafting (CABG) surgery in which different oxygenation systems will be used.
Detailed description
In order to assess the efficacy and safety of fusion Oxygenation System in patients undergoing isolated CABG, a prospective one-to-one randomized trial comparing the fusion oxygenation to the currently used affinity oxygenation system will be conducted. Forty patients intending to undergo CABG will be divided into 2 groups according to the oxygenation system which will be used during surgery. Distribution into groups will be done randomly. Ten patients undergoing elective peripheral vascular surgical procedures under general anesthesia and 10 patients undergoing elective percutaneous coronary intervention will serve as control groups for the neurological outcomes. Clinical status, inflammatory and hematological response as well as Neurological outcome will be assessed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fusion oxygenation system | Active comparator | Device: fusion oxygenation systemFusion oxygenation machine will be used during the operation. |
| Affinity oxygenation system | Active comparator | Device: Affinity oxygenation systemAffinity oxygenation machine will be used during the operation. |
| Peripheral vascular procedure | No intervention | –No oxygenation machine will be used in this group |
| percutaneous coronary intervention | No intervention | –No oxygenation machine will be used in this group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (18-75 years old) undergoing first-time, isolated CABG at the Hebrew University, Hadassah Medical Center, Jerusalem, Israel and the University Hospital of Angers, Angers, France.
- Patients undergoing elective peripheral vascular surgical procedures under general anesthesia
- Patients undergoing elective percutaneous coronary intervention will serve as control groups
Key exclusion criteria (6 listed)
- Emergency operations
- Left ventricular ejection fraction less than 30%
- CABG with concomitant procedure
- Previous stroke or documented neurological disorder
- High grade (>70%) unilateral or bilateral carotid stenosis
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 |
|---|---|---|
| fusion oxygenation systemThe fusion oxygenation system is a novel design of the pump oxygenator used in cardiopulmonary bypass, integrating multiple new engineering concepts that have altered its performance profile. | Device | Fusion oxygenation system |
| Affinity oxygenation systemThe affinity oxygenation system is the classical pump oxygenator used in cardiopulmonary bypass surgeries | Device | Affinity oxygenation system |
Primary outcome
major adverse events
Time frame: Participants will be followed for 30 days following the surgery
Number of major adverse events (including mortality) will be assessed
5 secondary outcomes
Systemic inflammatory response
Time frame: Participants will be followed 3 days following the surgery.
Number of participants with abnormal laboratory values
Time frame: Participants will be followed for 3 days following the surgery.
Neurological outcomes-Functional magnetic resonance imaging (MRI)
Time frame: Changes in brain activity pattern will be assessed at baseline and 4 weeks postoperatively .
Neurological outcomes-Transcranial Doppler (TCD)
Time frame: Participants will be followed 3 days following the surgery.
Neurological outcomes- electroencephalogram (EEG)
Time frame: Participants will be followed 3 days following the surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
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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.
Oz Shapira, MD principal investigator
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
A study testing fusion oxygenation system and Affinity oxygenation system in people with Complication of Coronary Artery Bypass Graft, run by Hadassah Medical Organization.
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: status not confirmed, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oz Shapira, MD (972-2-6776960, Ozshapira@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse events (time frame: Participants will be followed for 30 days following the surgery). 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 18 Sep 2015.