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Hypothermic Oxygenated Perfusion Versus Static Cold Storage for Marginal Graft (PIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031067
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Matteo Ravaioli, University of Bologna

Brief 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.


Condition or disease Intervention/treatment Phase
Liver Diseases Kidney Diseases Device: Machine perfusion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Official Title: Comparison Between Hypothermic Oxygenated Perfusion and Static Cold Storage of Organ From Extended Criteria Donors
Study Start Date : October 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: Machine perfusion - Kidney
The marginal kidney will be perfused with oxygenated solution of preservation at 4°C for two hours with Exiper, Bologna Machine Perfusion.
Device: Machine perfusion

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 Name: Hypothermic Oxygenated Perfusion

No Intervention: Static cold storage - Kidney
The marginal kidney that was stored to cold (SCS), previously.
Experimental: Machine perfusion - Liver
The marginal liver will be perfused with oxygenated solution of preservation at 4°C for two hours with Exiper, Bologna Machine Perfusion.
Device: Machine perfusion

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 Name: Hypothermic Oxygenated Perfusion

No Intervention: Static cold storage - Liver
The marginal liver that was stored to cold (SCS), previously.



Primary Outcome Measures :
  1. Graft function [ Time Frame: 3 months post-transplantation (+18/-2 months) ]
    Physiological values of serum creatinine and diuresis for kidney transplantation and bilirubin, AST, ALT, INR for liver transplantation


Secondary Outcome Measures :
  1. Graft survival - Kidney [ Time Frame: 3 months post-transplantation (+18/-2 months) ]
    Time (days) of graft survival

  2. Graft survival - Liver [ Time Frame: 3 months post-transplantation (+18/-2 months) ]
    Time (days) of graft survival

  3. Patient survival (kidney recipient) [ Time Frame: 3 months post-transplantation (+18/-2 months) ]
    Time (days) of patient survival

  4. Patient survival (liver recipient) [ Time Frame: 3 months post-transplantation (+18/-2 months) ]
    Time (days) of patient survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kidney donor: ECD.
  • Kidney recipient: single or dual kidney transplant recipients at our center, provided consent.
  • Liver donor: ECD
  • Liver recipient: liver transplant recipients at our center, provided consent.

Exclusion Criteria:

  • Kidney donor: no ECD, donor with vascular anatomical abnormalities and/or urinary tract, donor with a risk infection, to increase cold ischemia time can not be avoided.
  • Kidney recipient: patients with severe atherosclerotic vascular disease, pathologies predisposing to the onset of intra-operative surgical complications, such as thrombophilia and hemophilia, antigenic incompatibility with donor determining the acute rejection of the organ; patients waiting for kidney transplant pre-emptive, multi-organ transplant, retransplantation.
  • Liver donor: no ECD, donor with vascular anatomical abnormalities, donor with a risk infection, to increase cold ischemia time can not be avoided.
  • Liver recipient: patients with acute liver disease and with vascular abnormalities and/or biliary tract requiring non-conventional reconstructive techniques, patients waiting for multi-organ transplant, retransplantation, urgency transplant ( or with MELD>30).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031067


Locations
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Italy
Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
Bologna, Italy, 40138
Sponsors and Collaborators
Matteo Ravaioli
Investigators
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Principal Investigator: Matteo Ravaioli, PhD University of Bologna S. Orsola-Malpighi Hospital, Transplantation and General Surgery Unit
Study Director: Antonio Daniele Pinna, Professor University of Bologna S. Orsola-Malpighi Hospital, Transplantation and General Surgery Unit
Publications:
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Responsible Party: Matteo Ravaioli, Principal Investigator, University of Bologna
ClinicalTrials.gov Identifier: NCT03031067    
Other Study ID Numbers: PIO-700
159/2015/O/Disp ( Registry Identifier: ID ethics committee )
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be performed by application of a single code.
Keywords provided by Matteo Ravaioli, University of Bologna:
Donors and donation
Extended criteria donor
Organ perfusion and preservation
Liver transplantation
Kidney transplantation
Preservation injury
Ischemia reperfusion injury
Additional relevant MeSH terms:
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Liver Diseases
Kidney Diseases
Urologic Diseases
Digestive System Diseases