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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
OCS Liver will be used to preserve the donor liver
St. James's University Hospital
Leeds, West Yorkshire, United Kingdom
Number of donor livers preserved by OCS in a near physiologic state.
Time frame: 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
Time frame: Within 1 day of organ retrieval
Number of donor livers maintained in a metabolically active and functioning state during preservation.
Time frame: 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.
Time frame: Within 1 day of organ retrieval
Frequency of liver graft-related serious adverse events
Time frame: 30 days after transplantation
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