NCT02860364 Comparing Hypothermic Temperatures During Hemiarch Surgery
| NCT ID | NCT02860364 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Thoracic Aortic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 282 participants |
| Start Date | 2018-02-20 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 282 participants in total. It began in 2018-02-20 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Munir Boodhwani, MD
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT02860364 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thoracic Aortic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02860364 currently recruiting?
Yes, NCT02860364 is actively recruiting participants. Contact the research team at jappoo@ucalgary.ca for enrollment information.
Where is the NCT02860364 trial being conducted?
This trial is being conducted at Boston, United States, Ridgewood, United States, Columbus, United States, Kelowna, Canada and 8 additional locations.
Who is sponsoring the NCT02860364 clinical trial?
NCT02860364 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Munir Boodhwani, MD at Ottawa Heart Institute Research Corporation. The trial plans to enroll 282 participants.