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The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective cohort | |||
| Prospective PleuralFlow cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of interventions to Treat Retained Blood Syndrome | Retained Blood Syndrome (RBS) is defined by a composite endpoint of specific reoperation for bleeding, pericardial effusion, and hemothorax. | Discharge from operating room for index-surgery through hospital discharge - approximate 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of episodes of new on set of post operative atrial fibrillations (POAS) | 30 day | |
| Number of readmissions for any diagnosis of RBS or POAS re-occurrences | 30 day |
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Inclusion Criteria:
Exclusion Criteria:
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The control arm consists of a cohort of matched cardiac surgery patients with data entered over the preceding 12 to 24-month period. The site will consecutively enroll a cohort of cardiac surgery patients in the treatment arm.
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| Name | Affiliation | Role |
|---|---|---|
| John Stulak, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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