Testing Hypothermic circulatory arrest for thoracic aortic disease
Official title: Comparing Hypothermic Temperatures During Hemiarch Surgery
A Randomized Controlled Trial of Mild vs. Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery With Anterograde Cerebral Perfusion
- 2 groups
- Sites in Kelowna, Surrey and 7 more cities
- Recruiting
Interventions
- Medical procedure
Hypothermic circulatory arrest
During cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury.
Canadian Sites (9)
7 of 9 recruiting
- Recruiting
Kelowna General Hospital
Kelowna, British Columbia
- Recruiting
Fraser Health Authority
Surrey, British Columbia
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario
- Recruiting
University Health Network
Toronto, Ontario
- Recruiting
Montreal Heart Institute
Montreal, Quebec
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec
- Not yet recruiting
University of British Columbia
Vancouver, British Columbia
- Not yet recruiting
Dalhousie university
Halifax, Nova Scotia
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 18 years
- +Planned unilateral selective anterograde cardioplegia
- +Anticipated lower body arrest time of \< 20 minutes
- +Able to provide written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Elective aortic hemiarch surgery
Exclusion
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- −Participation in another clinical trialInterventional studyA study where participants are given something to see what happens.Read more → which interferes with performance of the study procedures or assessment of the outcomes
- −Surgery for acute aortic dissection or emergent operations
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Hypothermic circulatory arrest.
Registry label: A: Mild Hypothermic Circulatory Arrest
Group B, the comparison group, receives Hypothermic circulatory arrest.
Registry label: B: Moderate Hypothermic Circulatory Arrest
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 282 people.
The study is currently expected to finish around December 2030.
The main measurement is taken over: Up to 90 days after surgery.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Composite endpointEndpointThe specific thing a study measures to answer its question.Read more → of neurologic and acute kidney injury — measured over Up to 90 days after surgery.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT02860364 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Hypothermic circulatory arrestProcedure
During cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 90 days after surgery..
The study as a whole is currently expected to finish around 2030-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 282 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 9 locations, including: Kelowna, British Columbia, Canada; Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada, and 3 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Hypothermic circulatory arrest is an important surgical technique, allowing complex aortic surgeries to be performed safely. Hypothermic circulatory arrest provides protection to cerebral and visceral organs, but may result in longer cardiopulmonary bypass times during surgery, increased risks of bleeding, inflammation, and neuronal injury. To manage these consequences, a trend towards warmer core body temperatures during circulatory arrest has emerged. This trial will randomize patients to either mild (32°C) or moderate (26°C) hypothermia during aortic hemiarch surgery to determine if mild hypothermia reduces the length of cardiopulmonary bypass time and other key measures of morbidity and mortality.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.