Back to resultsTargeted Hypothermia During Cardiac Surgery
Primary Purpose
Cardiac Surgery
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
NeuroSave device
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Surgery
Eligibility Criteria
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
Sites / Locations
- The Alfred Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NeuroSave Device
Arm Description
Targeted Hypothermia with NeuroSave Device
Outcomes
Primary Outcome Measures
Freedom from major adverse events related to the use of the NeuroSave device
Secondary Outcome Measures
Brain-core temperature differential during cardiac surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01894724
Brief Title
Targeted Hypothermia During Cardiac Surgery
Official Title
Targeted Cerebral Hypothermia During Cardiac Surgery: A Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroSave Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NeuroSave Device
Arm Type
Experimental
Arm Description
Targeted Hypothermia with NeuroSave Device
Intervention Type
Device
Intervention Name(s)
NeuroSave device
Primary Outcome Measure Information:
Title
Freedom from major adverse events related to the use of the NeuroSave device
Time Frame
Surgery through discharge (up to 5 days post-surgery)
Secondary Outcome Measure Information:
Title
Brain-core temperature differential during cardiac surgery
Time Frame
Continuously assessed over course of cardiac surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvanna Marasco
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Targeted Hypothermia During Cardiac Surgery
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