Targeted Hypothermia During Cardiac Surgery

NeuroSave

Status and phase

Completed

Phase 1

Conditions

Cardiac Surgery

Treatments

Device: NeuroSave device

Study type

Interventional

Funder types

Other

Identifiers

NCT01894724

CS-1.0

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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