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To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial
To provide continued access for the LLT System with Vasosol® for the preservation of whole explanted livers, thereby providing additional safety data in support of the PILOT pivotal efficacy and safety trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypothermic Machine Perfusion | Experimental | Hypothermic Machine Perfusion with Organ Recovery Systems LifePort Liver Transporter system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypothermic Machine Perfusion | Device | Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early Allograft Dysfunction (EAD) | EAD defined as total bilirubin ≥ 10 mg/dL or International Normalized Ratio (INR) ≥ 1.6 or Aspartate Aminotransferase (AST) >2000IU/L or Alanine Aminotransferase (ALT) > 2000 IU/L | 7 days |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carrie Lindower | Organ Recovery Systems | Study Director |
| Matthew Copithorne | Organ Recovery Systems | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States | ||
| University of Chicago Medical Center |
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| Chicago |
| Illinois |
| 60637 |
| United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07101 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |