Antegrade versus retrograde brain perfusion during low-moderate hypothermia for aortic hemi-arch surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares two methods of supplying blood to the brain (antegrade versus retrograde cerebral perfusion) during circulatory arrest with low-to-moderate hypothermia for proximal aortic reconstructive surgery including hemi-arch replacement. Patients undergo the planned surgical procedure and receive one of the two perfusion approaches while the heart-lung machine is stopped. Cognitive function is measured before and after surgery using standardized screening and testing (including MoCA and mood/depression scales) to track confusion, delirium, and agitation. The trial is conducted at Duke University and enrolls eligible adult surgical patients who can complete the cognitive testing.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

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

Where it's running

• Duke Univeristy
  Durham, North Carolina, United States Recruiting
• Duke Univeristy
  Durham, North Carolina, United States Not yet recruiting

Study contacts

• Study coordinator: Kelly Rodden, BSN
• Email: Kelly.Rodden@duke.edu
• Phone: 9196811804

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brain and metabolic responses to different macronutrients in people with obesity

  This trial will test whether three small, isocaloric liquid meals (glucose, fat, or protein) change brain activity and blood metabolites in adults with obesity and healthy-weight adults.

  Recruiting The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT07392905

• Evaluating brain function and psychological effects of cell therapy in autoimmune hemolytic anemia

  This study is testing how CAR T-cell therapy affects thinking and mental health in people with autoimmune hemolytic anemia to help improve their treatment and quality of life.

  Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT06921980

• Whole-brain activity during a natural menstrual cycle versus an ovarian stimulation cycle

  This research will test whether hormonal changes from ovarian stimulation change resting brain activity in healthy young women with regular cycles.

  Recruiting at 2 sites ART Fertility Clinics LLC · Abu Dhabi, Abu Dhabi Emirate and 1 other locations · NCT06910293

• Exploring brain function in action observation for patients with cerebral palsy

  This study is trying to see how the brains of people with cerebral palsy work when they watch actions, using advanced MRI scans to better understand their brain connections and how it relates to their condition.

  Recruiting IRCCS Fondazione Stella Maris · Calambrone, PISA and 1 other locations · NCT06826287

• Impact of early intervention on child development in foster care vs. institutional care

  This study is testing whether young children in foster care develop better than those in enhanced institutional care to see which option helps them grow up healthier.

  Recruiting Boston Children's Hospital · São Paulo, São Paulo · NCT04165746

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.