Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID02860364

Randomized Trial Comparing Mild Versus Moderate Hypothermia Effects on Outcomes in Aortic Hemiarch Surgery with Anterograde Cerebral Perfusion

Led by Ottawa Heart Institute Research Corporation · Updated on 2025-09-24

282

Participants Needed

12

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with thoracic aortic disease who need aortic hemiarch surgery to compare two body temperature approaches during circulatory arrest. The goal is to see if using mild hypothermia (326C) instead of moderate hypothermia (266C) can reduce the time on cardiopulmonary bypass and affect important outcomes like neurologic injury, kidney injury, bleeding, and other surgical risks. This is a randomized controlled trial sponsored by the Ottawa Heart Institute Research Corporation.

CONDITIONS

Brief Title

Comparing Hypothermic Temperatures During Hemiarch Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Scheduled for elective aortic hemiarch surgery
  • Planned unilateral selective anterograde cardioplegia
  • Expected lower body arrest time less than 20 minutes
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Surgery for acute aortic dissection or emergency operations
  • Total arch replacement surgery
  • Unable to perform unilateral selective anterograde cerebral perfusion
  • Known bleeding or clotting disorders
  • Cold agglutinin disease or positive preoperative screening for it
  • Severe neurological impairment or inability to assess neurocognitive function
  • Severe carotid artery disease as defined by specific stenosis criteria or previous carotid procedures
  • Renal failure or currently on renal replacement therapy or low kidney filtration rate
  • Use of investigational drug or device at enrollment
  • Participation in other clinical trials interfering with this study's procedures or assessments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate recovery period

Participants undergo aortic hemiarch surgery with either mild or moderate hypothermic circulatory arrest to reduce ischemic injury during the procedure.

1 surgery visit and hospital stay

Post-operative Follow-up

Duration - Up to 90 days after surgery

Participants are monitored for neurologic, kidney, and other health outcomes after surgery to assess recovery and complications.

Approximately 3 follow-up visits within 90 days

Trial Site Locations

Total: 12 locations

1

Massachusetts General

Boston, Massachusetts, United States, 02114

Actively Recruiting

2

The Valley Hospital

Ridgewood, New Jersey, United States, 07450

Actively Recruiting

3

Ohio State University Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

4

Kelowna General Hospital

Kelowna, British Columbia, Canada, V1Y 1T2

Actively Recruiting

5

Fraser Health Authority

Surrey, British Columbia, Canada, V3T 0H1

Actively Recruiting

6

University of British Columbia

Vancouver, British Columbia, Canada, V6Z 1Y6

Not Yet Recruiting

7

Dalhousie university

Halifax, Nova Scotia, Canada, B3H 3A7

Not Yet Recruiting

8

London Health Sciences Centre

London, Ontario, Canada, N6A 5A5

Actively Recruiting

9

University of Ottawa Heart Institute

Ottawa, Ontario, Canada, K1Y 4W7

Actively Recruiting

10

University Health Network

Toronto, Ontario, Canada, M5G 2N2

Actively Recruiting

11

Montreal Heart Institute

Montreal, Quebec, Canada, H1T 1C8

Actively Recruiting

12

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

Loading map...

Research Team

J

Jehangir Appoo, MD

A

Alice Black, BSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Accessing the Clarity and Acceptability of Recruitment Mater...

Thoracic Aortic Disease

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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.

Habib Jabagi, George Wells, Munir Boodhwani

https://pubmed.ncbi.nlm.nih.gov/31815641