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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fusion oxygenation system | Active Comparator | Fusion oxygenation machine will be used during the operation. |
|
| Affinity oxygenation system | Active Comparator | Affinity 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fusion oxygenation system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| major adverse events | Number of major adverse events (including mortality) will be assessed | Participants will be followed for 30 days following the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oz Shapira, MD | Contact | 972-2-6776960 | Ozshapira@hadassah.org.il | |
| Hadas Lemberg, PhD | Contact | 972- 2- 6777572 | lhadas@hadassah.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Oz Shapira, MD | Hadassah Medical Organization | Principal Investigator |
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| Affinity oxygenation system | Device | The affinity oxygenation system is the classical pump oxygenator used in cardiopulmonary bypass surgeries |
|
| 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. | 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. | 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. | 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. | Participants will be followed 3 days following the surgery. |