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Procedure

Hypothermia During Aortic Surgery (TITAN:COMMENCE Trial)

Montréal, Canada

N/A

Recruiting

Led By Munir Boodhwani, MD

Research Sponsored by Ottawa Heart Institute Research Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Elective aortic hemiarch surgery

Must not have

Surgery for acute aortic dissection or emergent operations

Total arch replacement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 hours after surgery.

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of two different temperatures on patients during aortic hemiarch surgery.

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Who is the study for?

This trial is for adults over 18 planning to undergo elective aortic hemiarch surgery with an expected lower body arrest time under 20 minutes. Participants must be able to consent and not have severe neurological issues, coagulopathies, severe carotid disease, renal failure, or cold agglutinin disease.Check my eligibility

What is being tested?

The study compares two levels of hypothermia during surgery: mild (32°C) versus moderate (26°C). It aims to see if milder temperatures can shorten cardiopulmonary bypass times and reduce complications related to bleeding, inflammation, and brain injury.See study design

What are the potential side effects?

Potential side effects include increased risk of bleeding due to longer bypass times when using hypothermic circulatory arrest technique. There may also be risks of inflammation and neuronal injury associated with the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for elective surgery on the upper part of my aorta.

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My surgery is expected to stop blood flow in my lower body for less than 20 minutes.

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I am scheduled for a specific heart surgery technique.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery for a sudden tear in my aorta.

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I have had a total arch replacement surgery.

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I have cold agglutinin disease or tested positive for it.

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I have severe narrowing in my neck arteries or had surgery/stenting for it.

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I am in renal failure or on dialysis, or my kidney function is very low.

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I cannot undergo a specific brain blood flow procedure.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days after surgery.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days after surgery.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days after surgery. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite endpoint of neurologic and acute kidney injury

Secondary study objectives

Death

Evaluate differences in the duration of cardiopulmonary bypass used in patients who receive mild or moderate hypothermic circulatory arrest during aortic hemiarch surgery

Incidence and quantity of perioperative blood transfusions

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