Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-04-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DHCA+RCP
Participants undergoing ascending aortic and hemiarch replacement will receive deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP).
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.
MHCA+uSACP
Participants undergoing ascending aortic and hemiarch replacement will receive moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP).
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Bradley Leshnower
Assistant Professor
Principal Investigators
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Bradley Leshnower, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Hospital
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Countries
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Other Identifiers
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IRB00087270
Identifier Type: -
Identifier Source: org_study_id