Aneurysm of Aortic ArchNCT00606190
Prospective Randomized Study of Brain Protection During Aortic Arch Replacement
A study testing Retrograde brain perfusion and Antegrade brain perfusion in people with Aneurysm of Aortic Arch, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate two standard approaches of supplying blood and oxygen to your brain during open heart surgery. Read more about this study
- Who is it for?
- Ages 21 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Aneurysm of Aortic Arch
- What is being tested?
- Retrograde brain perfusion and Antegrade brain perfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Apr 2010
- 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 21 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing a total arch replacement
- Less than 75 years old
Who cannot join
- EF less than 35%
- Pt shows evidence of major illness e.g. severe hepatic disease, severe renal failure, active cancer or major infection
- Pt unable to complete preop neuro assessment
- Pt is unwilling or able to complete followup requirements
- Pt is already enrolled in other new device or drug protocols that have not completed the primary endpoint or that clinically interferes with study endpoint
- Pt is a female who is pregnant or lactating
- Pt has history of stroke
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to evaluate two standard approaches of supplying blood and oxygen to your brain during open heart surgery.
Read the detailed description
The purpose of the clinical trial is to assess the best method of protecting the brain during long periods of circulatory arrest. The significance of this project will be to determine which method of brain protection (1) retrograde brain perfusion or (2) perfusion of the right subclavian artery with antegrade perfusion of the brain protects against brain injury after total arch replacement. Thus reducing the risk of stroke or neurocognitive deficits in patients undergoing this critical surgical procedure.
- Conditions
- Aneurysm of Aortic Arch
- Being tested
- Retrograde brain perfusion, Antegrade brain perfusion
- Medical subject headings
- Aneurysm, Aortic Arch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde brain perfusionProcedure or surgery
observational
Antegrade brain perfusionProcedure or surgery
observational
| Study group | Role | What they receive |
|---|---|---|
| Retrograde brain perfusion | Active comparator | Pt may be randomized to retrograde brain perfusion when having a repair of the ascending aortic artery (aorta) including the aortic arch. This is one of the standard methods used while the body and the brain are cooled down to sub-normal levels (hypothermia). This will take place while on the heart-lung machine. Receives: Procedure: Retrograde brain perfusion |
| Antegrade brain perfusion | Active comparator | Pt may be randomized to antegrade brain perfusion when having a repair of the ascending aortic artery (aorta) including the aortic arch. This is one of the standard methods used while the body and the brain are cooled down to sub-normal levels (hypothermia). This will take place while on the heart-lung machine. Receives: Procedure: Antegrade brain perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine what is the best method of brain protection during long periods of circulatory arrest
Measured: 6 months
Secondary outcomes (1)
Will one method of brain protection be better than the other in prevention of post-op stroke and which method will provide freedom from postop neurobehavioural deficit at 6 months postop.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2008 (estimated)
- Study startJun 2003
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aneurysm of Aortic ArchStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Svensson, MD, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606190
- Sponsor's protocol ID
- 5985 Aortic Arch
- Status last verified
- Feb 2017
- First submitted
- 27 Dec 2007
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Svensson LG, Blackstone EH, Apperson-Hansen C, Ruggieri PM, Ainkaran P, Naugle RI, Lima B, Roselli EE, Cooper M, Somogyi D, Tuzcu EM, Kapadia S, Clair DG, Sabik JF 3rd, Lytle BW. Implications from neurologic assessment of brain protection for total arch replacement from a randomized trial. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1140-7.e11. doi: 10.1016/j.jtcvs.2015.07.054. Epub 2015 Jul 26.
PubMed 26409997
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Brain Protection During Aortic Arch Replacement
- ClinicalTrials.gov ID
- NCT00606190
- Acronym / sponsor ID
- 5985 Aortic Arch
- Conditions
- Aneurysm of Aortic Arch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 1 Feb 2008 (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.
The purpose of this research study is to evaluate two standard approaches of supplying blood and oxygen to your brain during open heart surgery.
Detailed description
The purpose of the clinical trial is to assess the best method of protecting the brain during long periods of circulatory arrest. The significance of this project will be to determine which method of brain protection (1) retrograde brain perfusion or (2) perfusion of the right subclavian artery with antegrade perfusion of the brain protects against brain injury after total arch replacement. Thus reducing the risk of stroke or neurocognitive deficits in patients undergoing this critical surgical procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrograde brain perfusion | Active comparator | Procedure: Retrograde brain perfusionPt may be randomized to retrograde brain perfusion when having a repair of the ascending aortic artery (aorta) including the aortic arch. This is one of the standard methods used while the body and the brain are cooled down to sub-normal levels (hypothermia). This will take place while on the heart-lung machine. |
| Antegrade brain perfusion | Active comparator | Procedure: Antegrade brain perfusionPt may be randomized to antegrade brain perfusion when having a repair of the ascending aortic artery (aorta) including the aortic arch. This is one of the standard methods used while the body and the brain are cooled down to sub-normal levels (hypothermia). This will take place while on the heart-lung machine. |
Who may qualify
- Ages
- 21 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing a total arch replacement
- Less than 75 years old
Key exclusion criteria (7 listed)
- EF less than 35%
- Pt shows evidence of major illness e.g. severe hepatic disease, severe renal failure, active cancer or major infection
- Pt unable to complete preop neuro assessment
- Pt is unwilling or able to complete followup requirements
- Pt is already enrolled in other new device or drug protocols that have not completed the primary endpoint or that clinically interferes with study endpoint
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 |
|---|---|---|
| Retrograde brain perfusionobservational | Procedure or surgery | Retrograde brain perfusion |
| Antegrade brain perfusionobservational | Procedure or surgery | Antegrade brain perfusion |
Primary outcome
To determine what is the best method of brain protection during long periods of circulatory arrest
Time frame: 6 months
1 secondary outcome
Will one method of brain protection be better than the other in prevention of post-op stroke and which method will provide freedom from postop neurobehavioural deficit at 6 months postop.
Time frame: 6 months
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 17 Feb 2017.
- Derived from this study: PubMed 26409997Svensson LG, Blackstone EH, Apperson-Hansen C, Ruggieri PM, Ainkaran P, Naugle RI, Lima B, Roselli EE, Cooper M, Somogyi D, Tuzcu EM, Kapadia S, Clair DG, Sabik JF 3rd, Lytle BW. Implications from neurologic assessment of brain protection for total arch replacement from a randomized trial. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1140-7.e11. doi: 10.1016/j.jtcvs.2015.07.054. Epub 2015 Jul 26.
- Individual participant dataSharing planned: No
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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.
Lars Svensson, MD, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrograde brain perfusion and Antegrade brain perfusion in people with Aneurysm of Aortic Arch, run by The Cleveland Clinic at 1 site 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 2 inclusion and 7 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 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To determine what is the best method of brain protection during long periods of circulatory arrest (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00606190, which also lists 1 linked publication.
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 17 Feb 2017.