Targeted Hypothermia During Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Targeted Cerebral Hypothermia During Cardiac Surgery: A Feasibility Trial

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Device: NeuroSave device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age Undergoing coronary revascularization or valvular cardiac surgery The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Human Research Ethics Committee (HREC) of the respective clinical site The study patient agrees to comply with all study -related procedures Exclusion Criteria: Women known or suspected to be pregnant (as confirmed by a pregnancy test for all women of child-bearing age) Past history of cerebrovascular accident (stroke or TIA) History of clinically diagnosed active psychiatric conditions Emergency or salvage cardiac valve operations Body weight < 50 kg Leukopaenia (WBC < 3000 cell/mL), anaemia (Hgb < 11g/dL), Thrombocytopaenia (Plt < 50,000 cell/mL) Active upper GI bleeding within 3 months (90 days) prior to procedure Renal insufficiency (creatinine > 265 micromol/L) and/or renal replacement therapy at the time of screening Estimated life expectancy < 12 months (365 days) Structural abnormality or disease of nose, mouth, pharynx and oesophagus (excluding gastric reflux oesophagus disease), Currently participating in an investigational drug or another device study that would potentially impact the results of this study as determined by the PI. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuroSave Device<br>Targeted Hypothermia with NeuroSave Device | Device: NeuroSave device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain-core temperature differential during cardiac surgery |  | Continuously assessed over course of cardiac surgery |