Neurologic Injury Following Aortic Arch Replacement
Completed · Not applicable
Conditions studied: Aortic Arch Replacement, Hemi Arch Replacement
In brief
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.
Key facts
- Study ID
- NCT02750423
- Run by
- Emory University
- People needed
- 20
- Starts
- 2016-04-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2018-03-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- Right axillary artery cannulation, deep hypothermic circulatory arrest, retrograde cerebral perfusion
- Right axillary artery cannulation, moderate hypothermic circulatory arrest, unilateral selective antegrade cerebral perfusion
You may not qualify if…
- 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.
Where it is running
- Emory University Hospital — Atlanta, Georgia, United States
- Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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