Neurologic Injury Following Aortic Arch Replacement

Emory University

Status: Completed

Conditions: Hemi Arch Replacement; Aortic Arch Replacement

Treatments: Procedure: MHCA + SACP; Procedure: DHCA+RCP

Study type: Interventional

Funder types: Other

Identifiers

NCT02750423

IRB00087270

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

DHCA+RCP

Active Comparator group

Description:

Participants undergoing ascending aortic and hemiarch replacement will receive deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP).

Treatment:

Procedure: DHCA+RCP

MHCA+uSACP

Active Comparator group

Description:

Participants undergoing ascending aortic and hemiarch replacement will receive moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP).

Treatment:

Procedure: MHCA + SACP