Comparing Hypothermic Temperatures During Hemiarch Surgery

NCT ID: NCT02860364

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-20
• Study Completion Date: 2030-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mild Hypothermic Circulatory Arrest

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

Group Type: EXPERIMENTAL

Hypothermic circulatory arrest

Intervention Type: PROCEDURE

During cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury.

Moderate Hypothermic Circulatory Arrest

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

Group Type: ACTIVE_COMPARATOR

Hypothermic circulatory arrest

Intervention Type: PROCEDURE

During cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury.

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Munir Boodhwani, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

Massachusetts General

Boston, Massachusetts, United States

Site Status: RECRUITING

The Valley Hospital

Ridgewood, New Jersey, United States

Site Status: RECRUITING

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status: RECRUITING

Kelowna General Hospital

Kelowna, British Columbia, Canada

Site Status: RECRUITING

Fraser Health Authority

Surrey, British Columbia, Canada

Site Status: RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

Site Status: NOT_YET_RECRUITING

Dalhousie university

Halifax, Nova Scotia, Canada

Site Status: NOT_YET_RECRUITING

London Health Sciences Centre

London, Ontario, Canada

Site Status: RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Montreal Heart Institute

Montreal, Quebec, Canada

Site Status: RECRUITING

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

United States; Canada

Central Contacts

Jehangir Appoo, MD

Role: CONTACT

jappoo@ucalgary.ca

403-944-2515

Alice Black, BSc

Role: CONTACT

alblack@ottawaheart.ca

613-696-7230

References

Jabagi H, Wells G, Boodhwani M. COMMENCE trial (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. Trials. 2019 Dec 9;20(1):691. doi: 10.1186/s13063-019-3713-9.

Reference Type: DERIVED

PMID: 31815641 (View on PubMed)

Other Identifiers

20160408

Identifier Type: -

Identifier Source: org_study_id