Targeted Hypothermia During Cardiac Surgery

Targeted Cerebral Hypothermia During Cardiac Surgery: A Feasibility Trial

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Device: NeuroSave device

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NeuroSave Device; Targeted Hypothermia with NeuroSave Device	Device: NeuroSave device

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: NeuroSave Inc.
• Investigators: Principal Investigator: Silvanna Marasco, The Alfred

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: June 30, 2013
• First Submitted That Met QC Criteria: July 3, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Estimate): April 17, 2015
• Last Update Submitted That Met QC Criteria: April 15, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: CS-1.0