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Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).
Prospective, randomized, multi-center study to show safe and effective use of whole liver preservation via hypothermic machine perfusion (HMP) as compared to livers preserved by static cold storage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypothermic Machine Perfusion | Experimental | Hypothermic Machine Perfusion with Organ Recovery Systems LLT system |
|
| Static Cold Storage | Active Comparator | Standard of Care - Static Cold Storage |
|
| 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 |
|---|---|---|
| Number of patients in each arm with 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stan Harris | 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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| Static cold storage | Device | Static cold storage (standard of care) |
|
| Chicago |
| Illinois |
| 60637 |
| United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07101 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Rochester Strong Memorial Hospital | Rochester | New York | 14642 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| University of Virginia Hospital | Charlottesville | Virginia | 22903 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 24, 2026 |