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The purpose of this research study is to evaluate two standard approaches of supplying blood and oxygen to your brain during open heart surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retrograde brain perfusion | Procedure | observational |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To determine what is the best method of brain protection during long periods of circulatory arrest | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Svensson, MD, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26409997 | Derived | 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. |
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| ID | Term |
|---|---|
| D000094626 | Aneurysm, Aortic Arch |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
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| Antegrade brain perfusion |
| Procedure |
observational |
|
| D002318 |
| Cardiovascular Diseases |
| D001018 | Aortic Diseases |