313.5: Meeting Packed Red Blood Cell Requirement for the Transmedics Organ Care System (OCS) Liver Transplantation Trial (PROTECT Trial) At Henry Ford Hospital

Abstract

Introduction: In January 2016, HFHS Transplant Institute began the PROSPECT trial, an interventional trial studying normothermic preservation of the donated liver before transplant using the Liver Organ Care System (OCSTM). The Henry Ford Hospital Transfusion Service (TS) provided the required packed red blood cells (PRBC). Background: The TransMedics (OCSTM) liver trial was an international, randomized trial studying the intervention of a portable liver system to preserve donor livers for transplant. The system utilizes an oxygenated blood-based perfusate mixed with nutrient solution in normothermic perfusion for organ preservation. The TS provided PRBC needed for the study, final PRBC used dictated by the condition and size of the retrieved liver. TS study goal was to secure proper transfusion needs for liver perfusion while also adhering to blood inventory management. Methods: Organ procurement candidates for the PROTECT trial were selected based on pre-determined conditions and consented according to that protocol. Once the patient was consented and the liver transplantation was scheduled, the PROTECT trial team notified the TS,and 5 units of group O Positive, leukoreduced PRBC less than 10 days old were selected, and placed inside a temperature-controlled packaging container along with a remote temperature monitoring device. The container was then transported with the procurement team to the harvesting location. Once the insulated container was returned to the TS, the temperature-monitoring device information was uploaded to verify that the returned PRBC have been stored within their proper temperature limits. Results: The TS support for the PROTECT trial at HFHS occurred from January 2016 until September 2021. The table below shows the activity related to this trial. - Issued Utilized Returned Wasted PRBC units 240 132 104 4 In summary, 29/48 study events used 4 units; 3/48 study events used 5 units; on 15/48 events the organ harvesting was cancelled; all units returned had an acceptable temperature range and returned to the available inventory. For one study event, 4 PRBC were spiked in preparation for use in the perfusate prior to the event being cancelled. These PRBC were discarded and deemed wasted. Conclusions: During the PROTECT trial no PRBCs were wasted due to inappropriate storage conditions. The joint use of a temperature-controlled container and remote temperature monitoring device allowed for the appropriate return of unused PRBCs to the TS blood inventory, thus avoiding any wastage. Only 3/48 events used 5 units, the\us issuing 4 PRBC to meet the OCS™ support may suffice, further decreasing the risk for wastage of any PRBC units. After receiving FDA in September 2021, alternatives to maintain the required PRBC temperature should be addressed to minimize wastage at this time of limited blood availability for the support of the TransMedics Organ Care System (OCSTM) for liver organ perfusion.