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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01894724




Registration number
NCT01894724
Ethics application status
Date submitted
30/06/2013
Date registered
10/07/2013
Date last updated
17/04/2015

Titles & IDs
Public title
Targeted Hypothermia During Cardiac Surgery
Scientific title
Targeted Cerebral Hypothermia During Cardiac Surgery: A Feasibility Trial
Secondary ID [1] 0 0
CS-1.0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Surgery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - NeuroSave device

Experimental: NeuroSave Device - Targeted Hypothermia with NeuroSave Device


Treatment: Devices: NeuroSave device
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from major adverse events related to the use of the NeuroSave device
Timepoint [1] 0 0
Surgery through discharge (up to 5 days post-surgery)
Secondary outcome [1] 0 0
Brain-core temperature differential during cardiac surgery
Timepoint [1] 0 0
Continuously assessed over course of cardiac surgery

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
NeuroSave Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01894724
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Silvanna Marasco
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01894724