Trial Outcomes & Findings for Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation (NCT NCT05045794)

228 recipient subjects and donors were randomized (ITT population), 113 in the HOPE arm and 115 in the SCS arm. Following randomization, a total of 9 subjects (4 HOPE, 5 SCS) did not complete transplant surgery because of clinical contraindications that were unrelated to the study. None of the 4 liver grafts in the HOPE arm underwent any treatment with the investigational device prior to being clinically declined. 219 subjects completed transplant surgery (safety and mITT populations).

Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation

Proportion of participants with EAD by 7 days post-transplant (or at hospital discharge if prior to 7 days). Defined by the presence of one or more of the following outcomes: * Serum bilirubin ≥10 mg/dL at day 7 post-transplant * INR ≥1.6 at day 7 post-transplant * ALT or AST \>2000 IU/L within the first 7 days post-transplant

Graft survival is defined as absence of death or graft failure

Participant survival is defined as absence of death.

Graft survival is defined as absence of death or graft failure

Participant survival is defined as absence of death.

Model for Early Allograft Score (MEAF) is a continuous scoring system based on the subject's maximum labs within the first three days post transplant, alanine aminotransferase (ALT) and international normalized ratio (INR) plus day-3 bilirubin. The score ranges from 0-10 with 0 being the worst to 10 being the best and provides a grade for liver dysfunction severity.

Defined as early graft failure resulting in re-transplantation or death with no hepatic artery thrombosis or other detectible technical complications and with AST≥3000 IU/L and either INR≥2.5, arterial pH≤7.30, venous pH≤7.25 or serum lactate≥4mmol/L

Duration from initial ICU or floor admission to hospital discharge order (measured in days)

Duration from initial intensive care unit (ICU) admission to ICU discharge order (measured in days), patients that did not go to ICU were assumed '0' days

Includes patient that required RRT within 2 weeks post-transplantation; duration from until discontinuation of dialysis for \>2 weeks

Defined as the proportion of randomized donor/recipients to transplanted recipients

Rejections confirmed on biopsy were tabulated between the 2 groups.

Non-anastomotic strictures (NAS) were diagnosed by the blinded, central radiologist on cholangiograms (ERCP, MRCP)

UADE is defined as an adverse event that is serious and device related. UADE reporting is only applicable to the HOPE arm.

Steroid resistant acute cellular rejection (SRR) defined as treatment with anti-thymocyte globulin (ATG) after steroids for biopsy proven rejection (BPR).

Clinical significance of subjects in the DCD sub-group with radiologically diagnosed ischemic cholangiopathy diagnosed by the central, blinded radiologist was evaluated using clinical severity categories developed by the lead investigator in collaboration with select site principal investigators and the Data Safety Monitoring Board (DSMB)