Recruiting

Hypothermic Temperatures

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT02860364

Conditions

Thoracic Aortic Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypothermic circulatory arrest

Study Details

Brief summary:

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

Thoracic Aortic Disease

Study ID

NCT02860364

Start date

Feb 20, 2018

Status verified date

Sep, 2025

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

282 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mild Hypothermic Circulatory Arrest

During aortic hemiarch surgery, mild hypothermia (32°C) will be used during circulatory arrest.

active comparator: Moderate Hypothermic Circulatory Arrest

During aortic hemiarch surgery, moderate hypothermia (26°C) will be used during circulatory arrest.

Interventions

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.

Primary outcome measure

  • Composite endpoint of neurologic and acute kidney injury [ Time Frame: Up to 90 days after surgery. ]

Central Contacts and Locations

Central contacts

Jehangir Appoo, MD

403-944-2515jappoo@ucalgary.ca

Alice Black, BSc

613-696-7230alblack@ottawaheart.ca

Locations

Massachusetts General

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Arminder Jassar, MD

The Valley Hospital

Recruiting

Ridgewood, New Jersey, United States, 07450

Principal Investigator:

Jabagi Habib, MD

Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Jovan Bozinovski, MD

Kelowna General Hospital

Recruiting

Kelowna, British Columbia, Canada, V1Y 1T2

Principal Investigator:

Calvin Wan, MD

Fraser Health Authority

Recruiting

Surrey, British Columbia, Canada, V3T 0H1

Principal Investigator:

Keerit Tauh, MD

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Principal Investigator:

Michael Chu, MD

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Principal Investigator:

Munir Boodhwani

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Principal Investigator:

Maral Ouzounian, MD

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Principal Investigator:

Philippe Demers

Institut universitaire de cardiologie et de pneumologie de Québec

Recruiting

Québec, Quebec, Canada, G1V 4G5

Principal Investigator:

Francois Dagenais, MD

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2025-09-24.