Neurologic Injury Following Aortic Arch Replacement

Not Applicable

Completed

• Conditions: Hemi Arch Replacement; Aortic Arch Replacement
• Interventions: Procedure: DHCA+RCP; Procedure: MHCA + SACP

• Registration Number: NCT02750423
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-21
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-25
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHCA+RCP	DHCA+RCP	Participants undergoing ascending aortic and hemiarch replacement will receive deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP).
MHCA+uSACP	MHCA + SACP	Participants undergoing ascending aortic and hemiarch replacement will receive moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP).

Primary Outcome Measures

Name	Time	Method
Rate of Neurologic Injury assessed by Magnetic Resonance Imaging (MRI)	Duration of Study (Up to 180 days)	The number of participants with evidence of neurologic injury assessed by MRI.
Change in Verbal Memory Test Score	Post Operative Visit Day 1, Post Operative Visit Day 180	The verbal memory test measures how many words participants can keep in short term memory at once. A higher score indicates better short term memory.
Incidence of Transient Ischemic Attack (TIA)	Duration of Study (Up to 180 days)	The number of participants with a new focal neurologic symptom lasting less than 24 hours without radiographic evidence of infarction.
Change in Finger Tapping Test Score	Post Operative Visit Day 1, Post Operative Visit Day 180	The finger-tapping test (FTT) is a neuropsychological test that examines motor functioning, specifically, motor speed and lateralized coordination. During administration, the participant's palm should be immobile and flat on the board, with fingers extended, and the index finder placed on the counting device. One hand at a time, participants tap their index finger on the lever as quickly as possible within a 10-s time interval, in order to increase the number on the counting device with each tap.
Change in Continuous Performance Test Score	Post Operative Visit Day 1, Post Operative Visit Day 180	The continuous performance test measures a participant's sustained and selective attention. Sustained attention is the ability to maintain a consistent focus on some continuous activity or stimuli, and is associated with impulsivity. Selective attention is the ability to focus on relevant stimuli and ignore competing stimuli. This skill is associated with distractibility.\[1\]
Change in Visual Memory Test Score	Post Operative Visit Day 1, Post Operative Visit Day 180	The visual memory test measures how many items a participant can keep in short term memory at once. A higher score indicates better short term memory.
Change in Symbol Digit Coding Score	Post Operative Visit Day 1, Post Operative Visit Day 180	The Digit symbol substitution test (DSST) is a neuropsychological test sensitive to brain damage, dementia, age and depression. It consists of nine digit-symbol pairs followed by a list of digits.Under each digit the participant should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
Change in Stroop Test Score	Post Operative Visit Day 1, Post Operative Visit Day 180	The Stroop effect is a demonstration of interference in the reaction time of a task. Participants will be asked the name of a color printed in a color not denoted by the name. Naming the color of the word takes longer and is more prone to errors than when the color of the ink matches the name of the color.
Change in Shifting Attention Test Score	Post Operative Visit Day 1, Post Operative Visit Day 180	The Shifting Attention Test measures a participant's executive functions (rules, categories, rapid decision making) or their ability to shift from one instruction set to another quickly and accurately.
Incidence of Stroke	Duration of Study (Up to 180 days)	The number of participants with a new focal neurologic deficit lasting greater than 24 hours that is confirmed by radiographic evidence of infarction.

Secondary Outcome Measures

Name	Time	Method
Incidence of Temporary Neurologic Deficit (TND)	Duration of Study (Up to 180 days)	The number of participants with a reversible, non-focal clinical neurologic injury without radiographic evidence of infarction.
Change in Serum S-100 Levels	Post Operative Visit Day 1, Post Operative Visit Day 180	Serum S-100 is a biomarker for neurologic injury found in blood serum.

Trial Locations

Locations (2)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory Saint Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States