Antegrade versus retrograde brain perfusion during low-moderate hypothermia for aortic hemi-arch surgery
Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
We will test whether giving blood to the brain in an antegrade versus a retrograde way better prevents confusion, delirium, or other thinking problems after elective proximal aortic reconstruction with hemi-arch replacement in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Trial ID | NCT06986967 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults over 18 scheduled for elective proximal aortic reconstructive surgery with proximal hemi-arch replacement who can complete baseline and follow-up cognitive testing and meet the study's medical criteria are the intended participants.
Not a fit: Patients with a history of symptomatic stroke with residual deficit, active substance abuse, current psychiatric illness requiring medication, severe organ failure, inability to read or complete cognitive tests, pregnant women, or those with low baseline cognitive scores are excluded and would not benefit from participation.
Why it matters
Potential benefit: If one perfusion method is superior, patients could have fewer postoperative cognitive problems such as confusion, delirium, or agitation.
How similar studies have performed: Previous comparisons of antegrade versus retrograde cerebral perfusion have produced mixed results without a clear consensus, so the question remains unresolved.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Durham, North Carolina and 1 other locations
- Duke Univeristy — Durham, North Carolina, United States (Not_yet_recruiting)
- Duke Univeristy — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Kelly Rodden, BSN
- Email: Kelly.Rodden@duke.edu
- Phone: 9196811804
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.