Targeted Hypothermia During Cardiac Surgery

NCT ID: NCT01894724

Last Updated: 2015-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-03-31

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.

Conditions

Cardiac Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NeuroSave Device

Targeted Hypothermia with NeuroSave Device

Group Type: EXPERIMENTAL

NeuroSave device

Intervention Type: DEVICE

Interventions

NeuroSave device

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuroSave Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvanna Marasco

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Locations

The Alfred Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

CS-1.0

Identifier Type: -

Identifier Source: org_study_id