Comparing Hypothermic Temperatures During Hemiarch Surgery (TITAN:COMMENCE)

  • STATUS
    Recruiting
  • End date
    Sep 10, 2023
  • participants needed
    282
  • sponsor
    Ottawa Heart Institute Research Corporation
Updated on 10 May 2022
Investigator
Jehangir Appoo, MD
Primary Contact
Fraser Health Authority (3.1 mi away) Contact
+3 other location

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.

Details
Condition Thoracic Aortic Disease
Treatment Hypothermic circulatory arrest
Clinical Study IdentifierNCT02860364
SponsorOttawa Heart Institute Research Corporation
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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
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