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This study designed to evaluate the safety and feasibility of the NeuroSave device to rapidly reduce brain temperature while maintaining the brain at a lower temperature than the body core during cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuroSave Device | Experimental | Targeted Hypothermia with NeuroSave Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroSave device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from major adverse events related to the use of the NeuroSave device | Surgery through discharge (up to 5 days post-surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Brain-core temperature differential during cardiac surgery | Continuously assessed over course of cardiac surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvanna Marasco | The Alfred | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
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