Hypothermic Machine Preservation-Phase 2
Condition: Liver Damage
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      This is a study comparing a technique of continuous circulation to the liver as a means of
      preventing liver damage during transportation to the transplant hospital. This new technique
      of Machine Perfusion (MP) will be compared to the standard technique where the liver is
      maintained in a bag of solution on ice without circulation. The investigators will evaluate
      and compare the outcomes of the transplants with the new technique to the standard technique.
      There will be 24 MP patient's in the study. The investigators have previously used this
      technique with success in 20 human liver transplant patients. The investigators think there
      will be a benefit in terms of less damage to and better function of the donor liver which
      will result in faster recovery for the patients. This protective effect may allow us to
      successfully transplant more patients and prevent people from dying while waiting for a liver
      transplant.
    

Detailed description: 
      It is our hypothesis that liver machine perfusion will increase the safe utilization of the
      existing supply of extended criteria donor (ECD) livers by (1) increasing the quality and
      duration of preservation thereby reducing the clinical effects reperfusion injury (2)
      improving early outcomes in patients receiving ECD liver allografts (3) developing reliable
      markers for pretransplant assessment of the potential graft (4) giving surgeons more
      confidence when transplanting ECD livers and (5) allowing an avenue for ex vivo manipulation
      of the liver to protect or restore a transiently injured liver.

      The proposed study is a matched cohort design. Potential subjects will be recruited from the
      Center for Liver Disease and Transplantation (CLDT) active Liver Transplant Waiting List. The
      Principal Investigator as well as the CoInvestigators, are all actively involved in the pre
      transplant evaluation process. Patients who are on the Waiting List and have provided written
      consent to receive an ECD graft will be recruited for this trial. Subjects will be matched
      with 24 historical control patients who received similar cold stored ECD grafts. Subjects
      will be matched on known covariates including donor age, donation after cardiac death,
      steatosis, both warm and cold ischemia times, recipient age, Model End-Stage Liver Disease
      (MELD) score and disease etiology.

      Subjects will be noncritically ill, not in an intensive care unit, and have a MELD < 35 in
      order to minimize the variability in outcome in the sickest patients. All subjects must
      provide written informed consent and meet the inclusion and exclusion criteria.

      Subjects will be followed for one year post transplantation, in conjunction with their
      routine liver transplant followup appointments. Retention of subjects for this trial will not
      be a challenge, in that the followup visit time points (postoperative days 1 through the
      discharge date, 7, 14, 30, 90, 180 and 365) are all consistent with our standard of care.
    

Intervention name(s): The Medtronic Portable Bypass System (PBS®)
Intervention type(s): Device
Intervention description(s): Will be used for machine perfusion of liver grafts.
Other intervention name(s): Medtronic Portable Bypass System (PBS®)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ECD liver transplant allografts; Hypothermic machine perfusion; Cold storage preservation; liver transplant; portable bypass system; machine perfusion preservation; extended criteria liver