Targeted Hypothermia During Cardiac Surgery

NCT01894724 | Completed Phase 1

• 1 other identifier: CS-1.0
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Freedom from major adverse events related to the use of the NeuroSave device

  Surgery through discharge (up to 5 days post-surgery)

Secondary Outcomes (1)

• Brain-core temperature differential during cardiac surgery

  Continuously assessed over course of cardiac surgery

Study Arms (1)

NeuroSave Device

EXPERIMENTAL

Targeted Hypothermia with NeuroSave Device

Device: NeuroSave device

Interventions

NeuroSave device DEVICE

NeuroSave Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuroSave Inc.: lead

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Study Officials

• Silvanna Marasco

  The Alfred

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2013
• First Posted: July 10, 2013
• Study Start: February 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

AU (1)