Targeted Hypothermia During Cardiac Surgery

Phase 1

Completed

• Conditions: Cardiac Surgery
• Interventions: Device: NeuroSave device

• Registration Number: NCT01894724
• Lead Sponsor: NeuroSave Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-30
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-10
• Study Start: 2014-02
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeuroSave Device	NeuroSave device	Targeted Hypothermia with NeuroSave Device

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Brain-core temperature differential during cardiac surgery	Continuously assessed over course of cardiac surgery

Trial Locations

Locations (1)

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia