Actively Recruiting
Comparing Hypothermic Temperatures During Hemiarch Surgery
Led by Ottawa Heart Institute Research Corporation · Updated on 2025-09-24
282
Participants Needed
12
Research Sites
666 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing Hypothermic Temperatures During Hemiarch Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �318 years
- Elective aortic hemiarch surgery
- Planned unilateral selective anterograde cardioplegia
- Anticipated lower body arrest time of < 20 minutes
- Able to provide written informed consent
You will not qualify if you...
- Surgery for acute aortic dissection or emergent operations
- Total arch replacement
- Inability to perform unilateral selective anterograde cerebral perfusion (uSACP)
- Known/documented coagulopathy
- Cold agglutinin disease or positive preoperative screening
- Severe pre-existing neurological impairment or inability to assess neurocognitive function
- Severe carotid disease as defined by degree of stenosis or prior carotid procedures
- Renal failure or current renal replacement therapy or eGFR < 30 ml/min/1.73m2
- Use of investigational drug or device at enrollment
- Participation in another conflicting clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Massachusetts General
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
Actively Recruiting
3
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
4
Kelowna General Hospital
Kelowna, British Columbia, Canada, V1Y 1T2
Actively Recruiting
5
Fraser Health Authority
Surrey, British Columbia, Canada, V3T 0H1
Actively Recruiting
6
University of British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Not Yet Recruiting
7
Dalhousie university
Halifax, Nova Scotia, Canada, B3H 3A7
Not Yet Recruiting
8
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Actively Recruiting
9
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
10
University Health Network
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
11
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
12
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
Actively Recruiting
Research Team
J
Jehangir Appoo, MD
CONTACT
A
Alice Black, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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