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Search / Trial NCT06986967

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

Launched by DUKE UNIVERSITY · May 22, 2025

Trial Information

Current as of July 27, 2025

Not yet recruiting

Keywords

Antegrade Perfusion Retrograde Perfusion Brain Perfusion Circulatory Arrest

ClinConnect Summary

This clinical trial is studying different methods of blood flow management during a type of heart surgery called aortic arch surgery. Specifically, the researchers want to understand how two techniques—antegrade perfusion and retrograde perfusion—affect brain function after the surgery. Essentially, they are comparing how well the brain performs when blood is circulated in different ways during a temporary halt in blood flow.

To be eligible for this study, participants need to be at least 18 years old and scheduled for specific heart surgeries, including aortic valve or root procedures along with a hemi-arch replacement. However, some people may not qualify due to certain health issues, like a history of strokes, severe liver or kidney problems, or current substance abuse. If you join the trial, you can expect to undergo cognitive tests to measure brain function before and after surgery, helping to provide valuable insights into the best practices for protecting brain health during these procedures.

Gender

ALL

Eligibility 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

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Joseph Mathew, M.D.

Study Chair

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported