RECRUITING

Comparing Hypothermic Temperatures During Hemiarch Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Controlled Trial of Mild vs. Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery With Anterograde Cerebral Perfusion

Quick Facts

Study Start:2018-02-20
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02860364

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Elective aortic hemiarch surgery
  3. * Planned unilateral selective anterograde cardioplegia
  4. * Anticipated lower body arrest time of \< 20 minutes
  5. * Able to provide written informed consent
  1. * Surgery for acute aortic dissection or emergent operations
  2. * Total arch replacement
  3. * Inability to perform unilateral selective anterograde cerebral perfusion (uSACP)
  4. * Patients with known/documented coagulopathy
  5. * Patients with cold agglutinin disease or those that test positive on routine preop screening
  6. * Pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon
  7. * 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
  8. * Patients in renal failure or currently being treated with renal replacement therapy (RRT) or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
  9. * Use of an investigational drug or device at time of enrollment
  10. * Participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes

Contacts and Locations

Study Contact

Jehangir Appoo, MD
CONTACT
403-944-2515
jappoo@ucalgary.ca
Alice Black, BSc
CONTACT
613-696-7230
alblack@ottawaheart.ca

Principal Investigator

Munir Boodhwani, MD
PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation

Study Locations (Sites)

Massachusetts General
Boston, Massachusetts, 02114
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
The Valley Hospital
Ridgewood, New Jersey, 07450
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Duke University Hospital
Durham, North Carolina, 27710
United States
Ohio State University Medical Center
Columbus, Ohio, 43210
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Baylor Scott & White Medical Center
Dallas, Texas, 75246
United States

Collaborators and Investigators

Sponsor: Ottawa Heart Institute Research Corporation

  • Munir Boodhwani, MD, PRINCIPAL_INVESTIGATOR, Ottawa Heart Institute Research Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-02-20
Study Completion Date2025-09

Study Record Updates

Study Start Date2018-02-20
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

  • Thoracic Aortic Disease