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Procedure
Hypothermia During Aortic Surgery (TITAN:COMMENCE Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours after surgery.
Awards & highlights
TITAN:COMMENCE Trial Summary
This trial will compare the effects of two different temperatures on patients during aortic hemiarch surgery.
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.
TITAN:COMMENCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
TITAN:COMMENCE Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite endpoint of neurologic and acute kidney injury
Secondary outcome measures
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
+9 moreTITAN:COMMENCE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mild Hypothermic Circulatory ArrestExperimental Treatment1 Intervention
During aortic hemiarch surgery, mild hypothermia (32°C) will be used during circulatory arrest.
Group II: Moderate Hypothermic Circulatory ArrestActive Control1 Intervention
During aortic hemiarch surgery, moderate hypothermia (26°C) will be used during circulatory arrest.
Find a Location
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,154 Total Patients Enrolled
Munir Boodhwani, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
1 Previous Clinical Trials
610 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery for a sudden tear in my aorta.I have had a total arch replacement surgery.You have a known blood clotting disorder.I have cold agglutinin disease or tested positive for it.I have severe narrowing in my neck arteries or had surgery/stenting for it.I am in renal failure or on dialysis, or my kidney function is very low.I am 18 years old or older.I am scheduled for elective surgery on the upper part of my aorta.My surgery is expected to stop blood flow in my lower body for less than 20 minutes.I cannot undergo a specific brain blood flow procedure.I am scheduled for a specific heart surgery technique.
Research Study Groups:
This trial has the following groups:- Group 1: Mild Hypothermic Circulatory Arrest
- Group 2: Moderate Hypothermic Circulatory Arrest
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there a significant number of hospitals running this trial in Canada?
"Patients are being accepted at this clinical trial in University of Manitoba, Montreal Heart Institute, Fraser Health Authority and 10 other locations."
Answered by AI
Can people with the qualifying condition participate in this research?
"That is correct, the clinical trial is still recruiting participants and has 282 slots open. The study was first posted on February 20th, 2018 and was updated most recently on April 26th, 2022. There are 10 sites currently participating in the trial."
Answered by AI
How many individuals are enrolled in this investigation?
"In order to move forward with this trial, we need 282 individuals that fit the bill in terms of specified inclusion criteria. Potential participants are located at University of Manitoba in Winnipeg, Manitoba and Montreal Heart Institute in Montréal, Quebec."
Answered by AI
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