Hypothermic Oxygenated Perfusion Versus Static Cold Storage for Marginal Graft
Condition: Liver Diseases; Kidney Diseases
MeSH terms: Liver Diseases; Kidney Diseases
Study type: Interventional

Summary: 
      One of the major challenge in the field of organ transplantation is the shortage of donor
      organs. Many patients waiting for organ transplantation die during the waiting time and many
      patients wait for organ transplantation many years with a detrimental effect on their quality
      of life, and increasing morbidity and the costs related to. Effective strategies, which
      safely extends the donor pool, are therefore advocated. During the last 20 years the two main
      policies to gain this purpose were the living donation and the utilization of extended
      donor's criteria (ECD). These donors are supposed to yield a lower outcome than the
      conventional donors and many research protocols were developed to reduce the preservation
      injury (PI) and PI-related complications. Static cold storage (SCS) has been the standard
      technique in clinical practice for liver and kidney preservation using particular solutions
      (Wisconsin, Custodiol and Celsior) able to prevent cellular swelling. Recently, graft
      preservation with hypothermic machine perfusion (HMP) is developing, because it seems to
      improve early graft function due to increased tissue ATP concentrations upon reperfusion and
      due to the continual flush of the microcirculation which removes waste products.

      The addition of oxygen during the perfusion represents an innovation in the methods of
      preservation in approved clinical setting seems to add further improvements of the graft. The
      present study was designed in order to assess the impact of hypothermic oxygenated perfusion
      (PIO) of marginal human kidney and liver compared with SCS.
    

Detailed description: 
      Our national single-center study, interventional with medical device, exploratory and safety,
      will be assessed the optimal graft preservation, liver and kidney, from marginal donors ECD
      (Expanded Criteria Donors), using hypothermic oxygenated perfusion (PIO) compared to the
      static cold storage that is the preservation control method of custom. PIO will be applied to
      10 ECD liver transplants and 10 ECD kidney transplants that meet the inclusion criteria.

      The marginal graft will be perfused with oxygenated solution of preservation at 4°C for two
      hours with Exiper, Bologna Machine Perfusion, developed by Medica s.p.a and our research
      group.

      Flow and pressure values will be set up for the kidney and liver perfusion, otherwise. The
      oxygenation of solution will be performed by an oxygenator and a filter for decapneization /
      oxygenation. During the perfusion the oxygen pressure will be required between 600-750 mmHg
      (pO2 80-100 Kpa), as reported in the scientific literature. The pH, lactate concentration,
      and oxygen (PO2) and carbon dioxide (PCO2) partial pressure were measured in the preservation
      solution at T0 and T1 by means of a standard haemogasanalyzer.

      After transplantation, the recipients will be monitored clinically to assess the graft
      function. The liver's data will be compared with similar case treated with SCS in our centre
      of transplant, retrospectively; instead, the kidney's data will be compared with the "twin"
      organ transplanted without PIO, prospectively.
    

Intervention name(s): Machine perfusion
Intervention type(s): Device
Intervention description(s): The graft preservation will be performed perfusing with a oxygenated solution of preservation at 4°C for two hours with Exiper, Bologna Machine Perfusion, developed by Medica s.p.a and our research group.
Flow and pressure values will be set up for the kidney and liver perfusion, differently. The oxygenation of solution will be performed by an oxygenator and a filter for decapneization / oxygenation. During the perfusion the oxygen pressure will be required between 600-750 mmHg (pO2 80-100 Kpa), as reported in the scientific literature. The pH, lactate concentration, and oxygen (PO2) and carbon dioxide (PCO2) partial pressure were measured in the preservation solution at T0 and T1 by means of a standard haemogasanalyzer.
Other intervention name(s): Hypothermic Oxygenated Perfusion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A matched-case analysis was developed: 10 HOPE-ECD livers and kidneys, HOPE-L and -K groups, were matched 1:3 with livers and kidneys preserved with static cold storage (SCS), SCS-L and -K groups respectively.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Donors and donation; Extended criteria donor; Organ perfusion and preservation; Liver transplantation; Kidney transplantation; Preservation injury; Ischemia reperfusion injury