Aortic Arch ReplacementNCT02750423
Neurologic Injury Following Aortic Arch Replacement
A study testing DHCA+RCP and MHCA + SACP in people with Aortic Arch Replacement and Hemi Arch Replacement, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Arch Replacement, Hemi Arch Replacement
- What is being tested?
- DHCA+RCP and MHCA + SACP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: Neurologic Injury AAR: Neurologic Injury Following Aortic Arch Replacement: A Comparison of Two Different Cerebral Protection Strategies (A Pilot Study)
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.
Read the 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.
- Conditions
- Aortic Arch Replacement, Hemi Arch Replacement
- Being tested
- DHCA+RCP, MHCA + SACP
- Keywords
- Cardiology, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHCA+RCPProcedure or surgery
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 + SACPProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| DHCA+RCP | Active comparator | Participants undergoing ascending aortic and hemiarch replacement will receive deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP). Receives: Procedure: DHCA+RCP |
| MHCA+uSACP | Active comparator | Participants undergoing ascending aortic and hemiarch replacement will receive moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP). Receives: Procedure: MHCA + SACP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Stroke
The number of participants with a new focal neurologic deficit lasting greater than 24 hours that is confirmed by radiographic evidence of infarction.
Measured: Duration of Study (Up to 180 days)
Incidence of Transient Ischemic Attack (TIA)
The number of participants with a new focal neurologic symptom lasting less than 24 hours without radiographic evidence of infarction.
Measured: Duration of Study (Up to 180 days)
Rate of Neurologic Injury assessed by Magnetic Resonance Imaging (MRI)
The number of participants with evidence of neurologic injury assessed by MRI.
Measured: Duration of Study (Up to 180 days)
Change in Verbal Memory Test Score
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.
Measured: Post Operative Visit Day 1, Post Operative Visit Day 180
Change in Visual Memory Test Score
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.
Measured: Post Operative Visit Day 1, Post Operative Visit Day 180
Change in Finger Tapping Test Score
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.
Measured: Post Operative Visit Day 1, Post Operative Visit Day 180
Change in Symbol Digit Coding Score
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.
Measured: Post Operative Visit Day 1, Post Operative Visit Day 180
Change in Stroop Test Score
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.
Measured: Post Operative Visit Day 1, Post Operative Visit Day 180
Change in Shifting Attention Test Score
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.
Measured: Post Operative Visit Day 1, Post Operative Visit Day 180
Change in Continuous Performance Test Score
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]
Measured: Post Operative Visit Day 1, Post Operative Visit Day 180
Secondary outcomes (2)
Incidence of Temporary Neurologic Deficit (TND)
The number of participants with a reversible, non-focal clinical neurologic injury without radiographic evidence of infarction.
Measured: Duration of Study (Up to 180 days)
Change in Serum S-100 Levels
Serum S-100 is a biomarker for neurologic injury found in blood serum.
Measured: Post Operative Visit Day 1, Post Operative Visit Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Arch ReplacementStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Leshnower, Emory University
- Investigators
- Bradley Leshnower, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750423
- Sponsor's protocol ID
- IRB00087270
- Status last verified
- Mar 2018
- First submitted
- 21 Apr 2016
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurologic Injury AAR: Neurologic Injury Following Aortic Arch Replacement: A Comparison of Two Different Cerebral Protection Strategies (A Pilot Study)
- ClinicalTrials.gov ID
- NCT02750423
- Acronym / sponsor ID
- IRB00087270
- Conditions
- Aortic Arch Replacement, Hemi Arch Replacement
- Keywords
- Cardiology, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHCA+RCP | Active comparator | Procedure: DHCA+RCPParticipants undergoing ascending aortic and hemiarch replacement will receive deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP). |
| MHCA+uSACP | Active comparator | Procedure: MHCA + SACPParticipants undergoing ascending aortic and hemiarch replacement will receive moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHCA+RCPDuring 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. | Procedure or surgery | DHCA+RCP |
| MHCA + SACPDuring 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. | Procedure or surgery | MHCA+uSACP |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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]
2 secondary outcomes
Incidence of Temporary Neurologic Deficit (TND)
Time frame: Duration of Study (Up to 180 days)
Change in Serum S-100 Levels
Time frame: Post Operative Visit Day 1, Post Operative Visit Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Leshnower, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHCA+RCP and MHCA + SACP in people with Aortic Arch Replacement and Hemi Arch Replacement, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Stroke (time frame: Duration of Study (Up to 180 days)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.