Thoracic Aortic DiseaseTITAN:COMMENCENCT02860364
Comparing Hypothermic Temperatures During Hemiarch Surgery
A study testing Hypothermic circulatory arrest in people with Thoracic Aortic Disease, run by Ottawa Heart Institute Research Corporation at 12 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Disease
- What is being tested?
- Hypothermic circulatory arrest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 20 Feb 2018to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 2 countries
Canada9 sites, 9 recruiting
- Not yet recruiting
Dalhousie university
Halifax, Nova Scotia, B3H 3A7
Christine Herman, MD
- Recruiting
Kelowna General Hospital
Kelowna, British Columbia, V1Y 1T2
Calvin Wan, MD
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5A5
Michael Chu, MD
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Philippe Demers
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Munir Boodhwani
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
Francois Dagenais, MD
- Recruiting
Fraser Health Authority
Surrey, British Columbia, V3T 0H1
Keerit Tauh, MD
- Recruiting
University Health Network
Toronto, Ontario, M5G 2N2
Maral Ouzounian, MD
- Not yet recruiting
University of British Columbia
Vancouver, British Columbia, V6Z 1Y6
Joel Price, MD
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General
Boston, Massachusetts, 02114
Arminder Jassar, MD
- Recruiting
Ohio State University Medical Center
Columbus, Ohio, 43210
Jovan Bozinovski, MD
- Recruiting
The Valley Hospital
Ridgewood, New Jersey, 07450
Juan Grau, MD
Jabagi Habib, MD
About this study
Official title: A Randomized Controlled Trial of Mild vs. Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery With Anterograde Cerebral Perfusion
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
- Being tested
- Hypothermic circulatory arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothermic circulatory arrestProcedure or surgery
During cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury.
| Study group | Role | What they receive |
|---|---|---|
| Mild Hypothermic Circulatory Arrest | Experimental | During aortic hemiarch surgery, mild hypothermia (32°C) will be used during circulatory arrest. Receives: Procedure: Hypothermic circulatory arrest |
| Moderate Hypothermic Circulatory Arrest | Active comparator | During aortic hemiarch surgery, moderate hypothermia (26°C) will be used during circulatory arrest. Receives: Procedure: Hypothermic circulatory arrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of neurologic and acute kidney injury
The primary objective of this study is to determine whether mild hypothermia (32°C) during aortic hemiarch surgery using unilateral selective anterograde cerebral perfusion (uSACP), is superior to moderate hypothermia (26°C) in reducing the composite endpoint of neurologic and acute kidney injury.
Measured: Up to 90 days after surgery.
Secondary outcomes (12)
Rates of Neurologic Injury
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to incidence of neurologic injury, including transient ischemic attack (TIA) and permanent neurological dysfunction (PND) or stroke.
Measured: Up to 90 days after surgery.
Incidence of Silent Strokes
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of silent strokes, defined as infarctions identified during magnetic resonance imaging (MRI) in patients without neurologic symptoms.
Measured: Up to 90 days after surgery.
Incidence of Acute Kidney Injury (AKI)
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of acute kidney injury (AKI), defined as Stage 1 or greater using the KDIGO criteria. Using the KDIGO criteria, Stage 1 AKI is defined as an increase in serum creatinine of 1.5-1.9x the baseline or an increase >= 27umol/L with urine output <0.5mL/kg/hour for 6-12 hours.
Measured: Up to 90 days after surgery.
Incidence of Delirium
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of delirium, using the Confusion Assessment Method (CAM). The Confusion Assessment Method defines delirium as the presence of acute changes in mental status with fluctuating course, plus inattention and the presence of either disorganized thinking OR altered level of consciousness.
Measured: Up to 90 days after surgery.
Death
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of death
Measured: Up to 90 days after surgery.
Evaluate differences in the duration of cardiopulmonary bypass used in patients who receive mild or moderate hypothermic circulatory arrest during aortic hemiarch surgery
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the length of time that the patient remains on cardiopulmonary bypass.
Measured: During the index procedure
Rates of Mediastinal re-exploration for bleeding
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the rates of mediastinal re-exploration (re-operation) for bleeding.
Measured: Up to 90 days after surgery.
Incidence and quantity of perioperative blood transfusions
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the number and quantity of perioperative blood transfusions
Measured: Up to 90 days after surgery.
Incidence of prolonged Mechanical Ventilation
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the duration of mechanical ventilation. Mechanical ventilation will be defined as use of a mechanical ventilator ≥48 hours.
Measured: Up to 90 days after surgery.
Perioperative Myocardial Infarction
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of perioperative myocardial infarction. This will be clinically diagnosed using a combination of electrocardiographic (new Q wave on 12 lead ECG) and/or biochemical (TnI > 45 ng/L) markers.
Measured: Up to 48 hours after surgery.
Length of Stay
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the duration of a patient's stay in the intensive care unit and on the hospital ward.
Measured: Up to 90 days after surgery.
Quality of life (SF-12)
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the patient's quality of life measured using the Short Form (SF) 12 questionnaire.
Measured: Up to 90 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start20 Feb 2018
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic Aortic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Munir Boodhwani, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860364
- Sponsor's protocol ID
- 20160408
- Acronym
- TITAN:COMMENCE
- Status last verified
- Sep 2025
- First submitted
- 4 Aug 2016
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Publications
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.
PubMed 31815641
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Mild vs. Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery With Anterograde Cerebral Perfusion
- ClinicalTrials.gov ID
- NCT02860364
- Acronym / sponsor ID
- TITAN:COMMENCE / 20160408
- Conditions
- Thoracic Aortic Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild Hypothermic Circulatory Arrest | Experimental | Procedure: Hypothermic circulatory arrestDuring aortic hemiarch surgery, mild hypothermia (32°C) will be used during circulatory arrest. |
| Moderate Hypothermic Circulatory Arrest | Active comparator | Procedure: Hypothermic circulatory arrestDuring aortic hemiarch surgery, moderate hypothermia (26°C) will be used during circulatory arrest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypothermic circulatory arrestDuring cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury. | Procedure or surgery | Mild Hypothermic Circulatory Arrest, Moderate Hypothermic Circulatory Arrest |
Primary outcome
Composite endpoint of neurologic and acute kidney injury
Time frame: Up to 90 days after surgery.
The primary objective of this study is to determine whether mild hypothermia (32°C) during aortic hemiarch surgery using unilateral selective anterograde cerebral perfusion (uSACP), is superior to moderate hypothermia (26°C) in reducing the composite endpoint of neurologic and acute kidney injury.
12 secondary outcomes
Rates of Neurologic Injury
Time frame: Up to 90 days after surgery.
Incidence of Silent Strokes
Time frame: Up to 90 days after surgery.
Incidence of Acute Kidney Injury (AKI)
Time frame: Up to 90 days after surgery.
Incidence of Delirium
Time frame: Up to 90 days after surgery.
Death
Time frame: Up to 90 days after surgery.
Evaluate differences in the duration of cardiopulmonary bypass used in patients who receive mild or moderate hypothermic circulatory arrest during aortic hemiarch surgery
Time frame: During the index procedure
Rates of Mediastinal re-exploration for bleeding
Time frame: Up to 90 days after surgery.
Incidence and quantity of perioperative blood transfusions
Time frame: Up to 90 days after surgery.
Incidence of prolonged Mechanical Ventilation
Time frame: Up to 90 days after surgery.
Perioperative Myocardial Infarction
Time frame: Up to 48 hours after surgery.
Length of Stay
Time frame: Up to 90 days after surgery.
Quality of life (SF-12)
Time frame: Up to 90 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Derived from this study: PubMed 31815641Jabagi 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.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Munir Boodhwani, MD principal investigator
Ottawa Heart Institute Research Corporation
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothermic circulatory arrest in people with Thoracic Aortic Disease, run by Ottawa Heart Institute Research Corporation at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jehangir Appoo, MD (403-944-2515, jappoo@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of neurologic and acute kidney injury (time frame: Up to 90 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02860364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.