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Neurologic Injury Following Aortic Arch Replacement

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ClinicalTrials.gov Identifier: NCT02750423
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Bradley Leshnower, 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.

Condition or disease Intervention/treatment Phase
Aortic Arch Replacement Hemi Arch Replacement Procedure: DHCA+RCP Procedure: MHCA + SACP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurologic Injury AAR: Neurologic Injury Following Aortic Arch Replacement: A Comparison of Two Different Cerebral Protection Strategies (A Pilot Study)
Actual Study Start Date : April 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: DHCA+RCP
Participants undergoing ascending aortic and hemiarch replacement will receive deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP).
Procedure: DHCA+RCP
During deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) the participant is placed on cardiopulmonary bypass (heart-lung machine) and their body temperature is lowered to a range of 14-18 °C. Once the goal temperature has been achieved, the circulation is stopped and aortic arch replacement is performed in a bloodless surgical field. Blood will be pushed to the brain through arterial vessels, much like the natural blood flow pattern. Once the aortic arch repair is complete, cardiopulmonary bypass is reinstituted, the participant is rewarmed, and separated from cardiopulmonary bypass.

Active Comparator: MHCA+uSACP
Participants undergoing ascending aortic and hemiarch replacement will receive moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP).
Procedure: MHCA + SACP
During moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA + SACP) the participant is placed on cardiopulmonary bypass (heart-lung machine0 and the native blood flow to the brain is temporarily suspended. The body is cooled to temperatures of ≤28°C and blood is administered to the brain via an artery in the neck during the period of arch reconstruction. Once the aortic arch repair is complete, cardiopulmonary bypass is reinstituted, the participant is rewarmed, and separated from cardiopulmonary bypass.




Primary Outcome Measures :
  1. Incidence of Stroke [ Time Frame: 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.

  2. Incidence of Transient Ischemic Attack (TIA) [ Time Frame: 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.

  3. Rate of Neurologic Injury assessed by Magnetic Resonance Imaging (MRI) [ Time Frame: Duration of Study (Up to 180 days) ]
    The number of participants with evidence of neurologic injury assessed by MRI.

  4. Change in Verbal Memory Test Score [ Time Frame: 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.

  5. Change in Visual Memory Test Score [ Time Frame: 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.

  6. Change in Finger Tapping Test Score [ Time Frame: 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.

  7. Change in Symbol Digit Coding Score [ Time Frame: 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.

  8. Change in Stroop Test Score [ Time Frame: 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.

  9. Change in Shifting Attention Test Score [ Time Frame: 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.

  10. Change in Continuous Performance Test Score [ Time Frame: 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]


Secondary Outcome Measures :
  1. Incidence of Temporary Neurologic Deficit (TND) [ Time Frame: Duration of Study (Up to 180 days) ]
    The number of participants with a reversible, non-focal clinical neurologic injury without radiographic evidence of infarction.

  2. Change in Serum S-100 Levels [ Time Frame: Post Operative Visit Day 1, Post Operative Visit Day 180 ]
    Serum S-100 is a biomarker for neurologic injury found in blood serum.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750423


Locations
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United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Bradley Leshnower, MD Emory University

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Responsible Party: Bradley Leshnower, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02750423     History of Changes
Other Study ID Numbers: IRB00087270
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Keywords provided by Bradley Leshnower, Emory University:
Cardiology
Surgery