Home › NCT02860364
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Hypothermic circulatory arrest (procedure)
Sponsor: Ottawa Heart Institute Research Corporation · Participants: 282 · Started: Feb 20, 2018
Contact the study team
- Jehangir Appoo, MD · Phone: 403-944-2515
- Alice Black, BSc · Phone: 613-696-7230
Official record on ClinicalTrials.gov — NCT02860364
Locations in the U.S.
| Massachusetts | Massachusetts General, Boston |
| New Jersey | The Valley Hospital, Ridgewood |
| Ohio | Ohio State University Medical Center, Columbus |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.