Pilot Study to Assess Safety and Feasibility of Normothermic Machine Preservation In Human Liver Transplantation
Condition: Liver Transplantation
Study type: Interventional

Summary: 
      Normothermic machine perfusion (NMP) preservation is a promising method to decrease the
      complication of marginal donor livers compared to cold storage (CS). The aim of this project
      is to assess safety and feasibility of NMP in human liver transplantation. This will be a
      single center prospective cohort pilot study. Thirty-two livers with acceptable quality for
      transplantation will be preserved with NMP in 2-18 hours and transplanted. The follow-up
      period will be 6 months post-transplantation. The outcome will be compared to 100 historical
      patients transplanted in our program in the past 5 years (liver preserved using CS) with
      matched characteristics on age, Model for End-Stage Liver Disease (MELD) score, preservation
      time, etc.
    

Detailed description: 
      The shortage of donor organs leads to the use of marginal donors including donors after
      cardiac death. Normothermic machine perfusion (NMP) preservation is a promising method to
      decrease their high risk of complication compared to the standard cold storage (CS). The aim
      of this project is to assess safety and feasibility of NMP in human liver transplantation.

      This will be a single center prospective cohort pilot study. Thirty-two livers that have
      acceptable quality for transplantation will be preserved with NMP in 2-18 hours after cross
      clamp and cold flush. The liver grafts at NMP will be at physiological temperature and have
      oxygen and nutrient supply with continuous perfusion. The transplantation and post-transplant
      care will follow the standard of care. The follow-up period is 12 months after
      transplantation. The primary end point will be the rate of post-transplant Early Allograft
      Dysfunction (EAD), while the secondary end points will be: primary non function (PNF) rate, 1
      and 6 months patient and graft survival, peak liver function tests in the first 7 days after
      transplantation, intraoperative hepatic arterial and portal flow measurement, rate and
      magnitude of post-reperfusion syndrome, surgical outcomes (operative time, transfusion
      requirement etc.), rate of post-transplant kidney failure, assessment of histological
      ischemia reperfusion (liver and bile duct), rate of vascular complications, rate of biliary
      complications, hospital and ICU length of stay, rejection rate, infection rate, the ability
      to predict function based on "on-pump" viability markers, and the incidence of adverse effect
      (AE).

      The outcome will be compared to a control group of 100 historical patients (matched with a
      1:4 ratio) transplanted in our program in the past 10 years (liver preserved using CS).
      Control subjects will be matched using donor and recipient age, Model for End-Stage Liver
      Disease (MELD) score, cold ischemia time, donor risk index and presence of steatosis.
    

Intervention name(s): Normothermic Liver perfusion Device
Intervention type(s): Device
Intervention description(s): The liver grafts will be preserved at physiological temperature and have continuous perfusion with oxygen and nutrient supply in the ex vivo organ preservation phase.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment