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The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.
The purpose of this study is to compare brain function after surgical circulatory arrest (surgeon stops the heart-lung machine to work on the heart) in antegrade perfusion versus retrograde perfusion. There are 2 ways to supply blood to the brain, antegrade and retrograde perfusion. In antegrade perfusion, the surgeon accesses one of two arteries that branch off from the aorta (the artery that delivers blood to the rest of the body) to provide blood to the brain. In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain.
It is standard practice to cool the patient down during this type of surgery to help protect the brain. Despite measures to safeguard brain health, some patients still experience postoperative cognitive decline such as confusion, delirium and agitation. The investigators are conducting this study to see which method of perfusing the brain is superior and decreases the symptoms of confusion, delirium and agitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Antegrade Perfusion | Active Comparator | In antegrade perfusion, the surgeon accesses one of two arteries that branch off from the aorta (the artery that delivers blood to the rest of the body) to provide blood to the brain. |
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| Arm 2: Retrograde Perfusion | Active Comparator | In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antegrade Perfusion | Procedure | Procedure in which the surgeon accesses one of two arteries that branch off from the aorta to provide blood to the brain. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in neurocognitive function as measured by the Montreal Cognitive Assessment (MoCA) | The MoCA is a brief screening tool used to assess cognitive function. It consists of 30 tasks covering various cognitive domains, including attention, memory, visuospatial abilities, and executive function. The total score ranges from 0 to 30, where a higher score indicates better cognitive function. | Baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on brain white matter patency | Measured by MRI at baseline, prior to discharge, and at 4 weeks. | Baseline, prior to discharge from hospital (up to 7 days), and at 4 weeks |
| Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on functional connectivity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly Rodden, BSN | Contact | 9196811804 | Kelly.Rodden@duke.edu | |
| Bonita Hilliard, RPM | Contact | bonita.hilliard@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joseph Mathew, M.D. | Duke University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Univeristy | Not yet recruiting | Durham | North Carolina | 27710 | United States |
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The neuroimaging personnel will be blinded to the assignment of the subject.
| Retrograde Perfusion | Procedure | Procedure in which the surgeon accesses the superior vena cava to supply blood to the brain. |
|
Measured by MRI at baseline and at 4 weeks. |
| Baseline and at 4 weeks |
| Duke Univeristy | Recruiting | Durham | North Carolina | 27710 | United States |
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