RECRUITING

Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery

Conditions

Brain Function Hemiarch Cardiac Procedure Antegrade Perfusion Retrograde Perfusion Brain Perfusion Circulatory Arrest

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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

The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.

Official Title

Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery

Quick Facts

Study Start:2025-04-18

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06986967

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 Criteria	Exclusion Criteria
1. \> 18 years of age 2. Participant's that are scheduled for elective proximal aortic reconstructive surgery (ascending aorta + aortic valve or root) with concomitant proximal hemi-arch replacement via median sternotomy	1. \< 18 years of age 2. history of symptomatic cerebrovascular disease, e.g., prior stroke with residual deficit 3. current alcoholism (\> 2 drinks/day) 4. current psychiatric illness requiring pharmacotherapy 5. current drug abuse (any illicit drug use in the past 3 months) 6. hepatic insufficiency (liver function tests \> 1.5 times the upper limit of normal) 7. severe pulmonary insufficiency (requiring home oxygen therapy) 8. renal failure (serum creatinine \> 2.0 mg/dL) 9. claustrophobic fear 10. unable to read and thus unable to complete the cognitive testing 11. pregnant women 12. patients who score \<19 om the Montreal Cognitive Assessment (MoCA) or ≥27 on the baseline Center for Epidemiological Studies Depression (CES-D) scale 13. patients who have pre-existing unsafe implants for 3 Tesla magnetic resonance imaging (MRI) 14. Patients who have received chemotherapy in the last 12 months or radiation to the brain

Inclusion Criteria

Exclusion Criteria

1. \> 18 years of age
2. Participant's that are scheduled for elective proximal aortic reconstructive surgery (ascending aorta + aortic valve or root) with concomitant proximal hemi-arch replacement via median sternotomy

1. \< 18 years of age
2. history of symptomatic cerebrovascular disease, e.g., prior stroke with residual deficit
3. current alcoholism (\> 2 drinks/day)
4. current psychiatric illness requiring pharmacotherapy
5. current drug abuse (any illicit drug use in the past 3 months)
6. hepatic insufficiency (liver function tests \> 1.5 times the upper limit of normal)
7. severe pulmonary insufficiency (requiring home oxygen therapy)
8. renal failure (serum creatinine \> 2.0 mg/dL)
9. claustrophobic fear
10. unable to read and thus unable to complete the cognitive testing
11. pregnant women
12. patients who score \<19 om the Montreal Cognitive Assessment (MoCA) or ≥27 on the baseline Center for Epidemiological Studies Depression (CES-D) scale
13. patients who have pre-existing unsafe implants for 3 Tesla magnetic resonance imaging (MRI)
14. Patients who have received chemotherapy in the last 12 months or radiation to the brain

Contacts and Locations

Study Contact

Kelly Rodden, BSN

CONTACT

9196811804

Kelly.Rodden@duke.edu

Bonita Hilliard, RPM

CONTACT

bonita.hilliard@duke.edu

Principal Investigator

Joseph Mathew, M.D.

STUDY_CHAIR

Duke University

Study Locations (Sites)

Duke Univeristy

Durham, North Carolina, 27710

United States

Duke Univeristy

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Duke University

Joseph Mathew, M.D., STUDY_CHAIR, Duke University

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 Date2025-04-18

Study Completion Date2027-03

Study Record Updates

Study Start Date2025-04-18

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

Antegrade Perfusion
Retrograde Perfusion
Brain Perfusion
Circulatory Arrest

Additional Relevant MeSH Terms

Brain Function
Hemiarch Cardiac Procedure