Targeted Hypothermia During Cardiac Surgery

Targeted Cerebral Hypothermia During Cardiac Surgery: A Feasibility Trial

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01894724

Enrollment

Registered

2013-07-10

Start date

2014-02-28

Completion date

2015-03-31

Last updated

2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Brief summary

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.

Interventions

DEVICENeuroSave device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Brain-core temperature differential during cardiac surgery	Continuously assessed over course of cardiac surgery

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026