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Completed

NCT Number: NCT01894724

Targeted Hypothermia During Cardiac Surgery

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeuroSave device

Device

Primary outcomes

  1. 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 outcomes

  1. Brain-core temperature differential during cardiac surgery

    Time frame: Continuously assessed over course of cardiac surgery

Sponsors and collaborators

Lead sponsor

NeuroSave Inc.

Other

Registry information

Official study title

Targeted Cerebral Hypothermia During Cardiac Surgery: A Feasibility Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2013
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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