Targeted Hypothermia During Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

Targeted Cerebral Hypothermia During Cardiac Surgery: A Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894724
• Other study ID #: CS-1.0
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2013
• Last updated: April 15, 2015
• Start date: February 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: NeuroSave Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery
• Hypothermia

Intervention

Device:
• NeuroSave device

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
NeuroSave Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from major adverse events related to the use of the NeuroSave device		Surgery through discharge (up to 5 days post-surgery)	Yes
Secondary	Brain-core temperature differential during cardiac surgery		Continuously assessed over course of cardiac surgery	No