Cooler or warmer? new trial tests best temperature for aortic surgery safety
NCT ID NCT02860364
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether cooling patients to 32°C (mild) or 26°C (moderate) during aortic arch surgery better protects the brain and kidneys. 282 adults having planned aortic hemiarch surgery will be randomly assigned to one temperature. The goal is to see which temperature reduces complications like stroke and kidney injury.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hypothermia (mild or moderate) during surgery
- What this could lead to
- If mild hypothermia works better, it could reduce brain and kidney damage after aortic surgery, leading to safer procedures and faster recovery.
- What could go wrong
- This is a mid-stage trial with 282 patients, so results may not apply to all. The difference between mild and moderate cooling might be small, and there are always risks from major surgery itself.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 282 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2018
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years * Elective aortic hemiarch surgery * Planned unilateral selective anterograde cardioplegia * Anticipated lower body arrest time of \< 20 minutes * Able to provide written informed consent Exclusion Criteria: * Surgery for acute aortic dissection or emergent operations * Total arch replacement * Inability to perform unilateral selective anterograde cerebral perfusion (uSACP) * Patients with known/documented coagulopathy * Patients with cold agglutinin disease or those that test positive on routine preop screening * Pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon * Severe carotid disease, defined as: any patient with previously documented carotid stenosis of \> 70% (via Doppler ultrasound (US), magnetic resonance angiography (MRA), or computer tomography angiography (CTA)) without neurological deficits; or carotid stenosis \> 50% with neurological deficits; or previous carotid endarterectomy or stenting * Patients in renal failure or currently being treated with renal replacement therapy (RRT) or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2 * Use of an investigational drug or device at time of enrollment * Participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dalhousie university
NOT_YET_RECRUITINGHalifax, Nova Scotia, B3H 3A7, Canada
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Fraser Health Authority
RECRUITINGSurrey, British Columbia, V3T 0H1, Canada
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Institut universitaire de cardiologie et de pneumologie de Québec
RECRUITINGQuébec, Quebec, G1V 4G5, Canada
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Kelowna General Hospital
RECRUITINGKelowna, British Columbia, V1Y 1T2, Canada
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London Health Sciences Centre
RECRUITINGLondon, Ontario, N6A 5A5, Canada
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Massachusetts General
RECRUITINGBoston, Massachusetts, 02114, United States
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Montreal Heart Institute
RECRUITINGMontreal, Quebec, H1T 1C8, Canada
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Ohio State University Medical Center
RECRUITINGColumbus, Ohio, 43210, United States
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The Valley Hospital
RECRUITINGRidgewood, New Jersey, 07450, United States
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University Health Network
RECRUITINGToronto, Ontario, M5G 2N2, Canada
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University of British Columbia
NOT_YET_RECRUITINGVancouver, British Columbia, V6Z 1Y6, Canada
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University of Ottawa Heart Institute
RECRUITINGOttawa, Ontario, K1Y 4W7, Canada
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