Clinical trial NCT02750423: Neurologic Injury Following Aortic Arch Replacement
Official title: Neurologic Injury AAR: Neurologic Injury Following Aortic Arch Replacement: A Comparison of Two Different Cerebral Protection Strategies (A Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Arch Replacement
Hemi Arch Replacement
Keywords: Cardiology
Surgery
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators are seeking to learn how well different cooling temperatures along with different blood flow pathways to the brain reduce the risk of injury to the brain in participants planning to undergo elective aortic arch and hemiarch surgery. Participants will be randomized to receive a cerebral protection strategy of either: deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) or moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP). Evidence of neurologic injury will be assessed with neurologic exams, neurocognitive tests, MRI imaging of the brain and measurement of plasma S-100 levels during post operative follow ups.

Detailed description: The purpose of this study is to investigate the impact of the two most commonly employed methods of cerebral protection upon mitigating neurologic injury in participants planning to undergo elective aortic arch and hemiarch surgery. Participants will be recruited from patients undergoing ascending aortic and hemiarch replacement using hypothermic circulatory arrest at Emory University Hospital and Emory Saint Joseph's Hospital. Participants will be randomized to receive a cerebral protection strategy of either: deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) or moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP). Evidence of neurologic injury will be assessed with neurologic exams, neurocognitive tests, MRI imaging of the brain and measurement of plasma S-100 levels during post operative follow up. Follow up visits will be conducted at Days 1, 3, 7, and 180 post operation.

Eligibility criteria: Inclusion Criteria:

Patients at Emory University Hospital and Emory Saint Joseph's Hospital planning to undergo:

* Elective surgical replacement of the ascending aorta and proximal ("hemiarch") using hypothermic circulatory arrest
* Concomitant cardiac procedures (e.g valve replacement, coronary artery bypass, etc.) in addition to ascending aortic and hemiarch replacement
* Any of the following cannulation and cerebral protection strategies:

  1. Right axillary artery cannulation, deep hypothermic circulatory arrest, retrograde cerebral perfusion
  2. Right axillary artery cannulation, moderate hypothermic circulatory arrest, unilateral selective antegrade cerebral perfusion

Exclusion Criteria:

* Undergoing total arch replacement
* Undergoing hemiarch replacement without the use of hypothermic circulatory arrest
* Undergoing hemiarch replacement using hypothermic circulatory arrest with a method of cerebral protection not listed in the Eligibility Criteria.
* Pregnant women or women who are nursing.

Primary outcomes:
measure: Incidence of Stroke
timeFrame: Duration of Study (Up to 180 days)
measure: Incidence of Transient Ischemic Attack (TIA)
timeFrame: Duration of Study (Up to 180 days)
measure: Rate of Neurologic Injury assessed by Magnetic Resonance Imaging (MRI)
timeFrame: Duration of Study (Up to 180 days)
measure: Change in Verbal Memory Test Score
timeFrame: Post Operative Visit Day 1, Post Operative Visit Day 180
measure: Change in Visual Memory Test Score
timeFrame: Post Operative Visit Day 1, Post Operative Visit Day 180
measure: Change in Finger Tapping Test Score
timeFrame: Post Operative Visit Day 1, Post Operative Visit Day 180
measure: Change in Symbol Digit Coding Score
timeFrame: Post Operative Visit Day 1, Post Operative Visit Day 180
measure: Change in Stroop Test Score
timeFrame: Post Operative Visit Day 1, Post Operative Visit Day 180
measure: Change in Shifting Attention Test Score
timeFrame: Post Operative Visit Day 1, Post Operative Visit Day 180
measure: Change in Continuous Performance Test Score
timeFrame: Post Operative Visit Day 1, Post Operative Visit Day 180
Secondary outcomes:
measure: Incidence of Temporary Neurologic Deficit (TND)
timeFrame: Duration of Study (Up to 180 days)
measure: Change in Serum S-100 Levels
timeFrame: Post Operative Visit Day 1, Post Operative Visit Day 180
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Bradley Leshnower, MD
role: PRINCIPAL_INVESTIGATOR
References: