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A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCS Liver | Experimental | OCS Liver will be used to preserve the donor liver |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCS Liver | Device | OCS Liver will be used to preserve the donor liver |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of donor livers preserved by OCS in a near physiologic state. | Within 1 day of organ retrieval | |
| Number of events directly related to the use of the OCS Liver that led to the donor liver being deemed not clinically acceptable and, as a result, not transplanted | Within 1 day of organ retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| Number of donor livers maintained in a metabolically active and functioning state during preservation. | Within 1 day of organ retrieval | |
| Number of donor livers monitored for perfusate temperatures, SvO2, hematocrit, Hepatic Artery flow rates, Portal Vein flow rate, Hepatic Artery pressure, Portal vein pressure, and bile production during preservation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. James's University Hospital | Leeds | West Yorkshire | LS9 7 TF | United Kingdom |
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| Within 1 day of organ retrieval |
| Frequency of liver graft-related serious adverse events | 30 days after transplantation |