<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03837197</url>
  </required_header>
  <id_info>
    <org_study_id>RF-2016-02364732</org_study_id>
    <nct_id>NCT03837197</nct_id>
  </id_info>
  <brief_title>Clinical Trial of New Hypothermic Oxygenated Perfusion System Versus Static Cold Storage</brief_title>
  <official_title>Expanded Criteria Donors in Liver and Kidney Transplantation: Protocol of a Randomised Single Center Clinical Trial of Hypothermic Oxygenated Perfusion Versus Static Cold Storage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bologna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      With the present study the investigators will evaluate the benefit of end-ischemic HOPE on&#xD;
      ECD grafts (livers and kidneys) as compared to SCS. Organs will be perfused through a&#xD;
      recently developed machine perfusion (MP) device, from the beginning of back-table procedures&#xD;
      till implantation, without increasing CIT. The aim of the study will be demonstrating the&#xD;
      ability of HOPE to improve graft function and post-operative outcomes of ECD kidney and liver&#xD;
      recipients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Extended criteria donors (ECD) are widely utilized due to organ shortage, but this may&#xD;
      increase the risk of graft dysfunction and of poorer outcomes.&#xD;
&#xD;
      Hypothermic oxygenated perfusion (HOPE) is a recent organ preservation strategy for marginal&#xD;
      kidney and liver grafts, which allows to redirect anaerobic metabolism to aerobic metabolism&#xD;
      under hypothermic conditions and to protect grafts from oxidative species-related damage;&#xD;
      these mechanisms may potentially improve graft function and survival.&#xD;
&#xD;
      Methods This is an open-label, randomized multicenter clinical trial with the aim of&#xD;
      comparing HOPE vs. static cold storage (SCS) in ECD kidney and liver transplantation.&#xD;
&#xD;
      In the study protocol - approved by ethics committee - 220 patients (110 liver recipients and&#xD;
      110 kidney recipients) will be enrolled. Livers and kidneys assigned to HOPE will be perfused&#xD;
      by machine perfusion with cold Belzer solution (4°-10°C) and with continuous oxygenation&#xD;
      (partial pressure of oxygen = 500-600 mmHg). In the control group, livers and kidneys&#xD;
      undergoing SCS will be steeped in Celsior or University of Wisconsin Belzer solutions and&#xD;
      stored in ice. Using the same perfusion machine for both liver and kidney grafts, organs will&#xD;
      be perfused from the start of the back-table procedure until implantation, without increasing&#xD;
      cold ischemia time (CIT). For each group the investigators will evaluate clinical outcomes,&#xD;
      graft function tests and histologic findings, as well as perfusate and the number of&#xD;
      allocated organs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 21, 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Liver Transplant - Early allograft dysfunction (EAD)</measure>
    <time_frame>0-30 days after procedure</time_frame>
    <description>Present/Non present</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kidney Transplant- Delayed graft function (DGF)</measure>
    <time_frame>0-30 days after procedure</time_frame>
    <description>Present/Non present</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Liver and Kidney surgical complications</measure>
    <time_frame>0-6 months after procedure</time_frame>
    <description>Present/Non present</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver and Kidney graft function at 6 and 12 months</measure>
    <time_frame>0-12 months after procedure</time_frame>
    <description>Functioning/non functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient survival at 6 and 12 months</measure>
    <time_frame>0-12 months after procedure</time_frame>
    <description>Alive/Death</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Liver Diseases</condition>
  <condition>Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>Kidney-Hypothermic oxygenated</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Belzer machine perfusion solution at 4°C-10°C in sterile conditions and continuous oxygenation (partial pressure of oxygen=500-600 mmHg) will be used for perfusion 2000 ml for kidneys.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kidney-Static Cold Storage</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Kidneys undergoing SCS will be stored in sterile organ bags with Celsior or University of Wisconsin solution and cooled in ice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liver-Hypothermic oxygenated</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Belzer machine perfusion solution at 4°C-10°C in sterile conditions and continuous oxygenation (partial pressure of oxygen=500-600 mmHg) will be used for perfusion 3000 ml for livers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liver-Static Cold Storage</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Livers undergoing SCS will be stored in sterile organ bags with Celsior or University of Wisconsin solution and cooled in ice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Kidney-Hypothermic oxygenated</intervention_name>
    <description>Kidney perfusion will be performed through the renal artery at 25-30 mmHg pressure.&#xD;
Flow, pressure and temperature will be monitored and registered on a Universal Serial Bus (USB) memory system during organ perfusion. Gas analysis of the effluent perfusate will be accomplished at the start of perfusion (T0) then every 30 minutes. Two perfusate samples will be collected at the beginning and at the end of perfusion to rule out bacterial or fungal contamination.&#xD;
HOPE will start by flushing the organ at low flow values (20 ml/min) with new oxygenated perfusion fluid during back-table preparation. Organ will be treated with continuous HOPE until transplant. Organ perfusion will be continuously monitored. Minimal perfusion time will be 2 hours for kidneys.</description>
    <arm_group_label>Kidney-Hypothermic oxygenated</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Liver-Hypothermic oxygenated</intervention_name>
    <description>Liver perfusion will be performed through the portal vein at a 5 mmHg pressure.&#xD;
Flow, pressure and temperature will be monitored and registered on a Universal Serial Bus (USB) memory system during organ perfusion. Gas analysis of the effluent perfusate will be accomplished at the start of perfusion (T0) then every 30 minutes. Two perfusate samples will be collected at the beginning and at the end of perfusion to rule out bacterial or fungal contamination.&#xD;
HOPE will start by flushing the organ at low flow values (30 ml/min) with new oxygenated perfusion fluid during back-table preparation. Organ will be treated with continuous HOPE until transplant. Organ perfusion will be continuously monitored. Minimal perfusion time will be 1 hour for livers.</description>
    <arm_group_label>Liver-Hypothermic oxygenated</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For kidneys: donor age ≥ 60 years or 50-59 years with two or more of the sequent risk&#xD;
             factors: death due to cerebrovascular accident, history of hypertension, donor serum&#xD;
             creatinine &gt; 1.5 mg/dL, cold ischemia time (CIT) &gt; 20 h;&#xD;
&#xD;
          -  For livers: donors with hemodynamic deterioration, donor age &gt; 65 years, donor body&#xD;
             mass index &gt; 30 kg/m2, serum bilirubin &gt; 3 mg/dl, AST or ALT above three times the&#xD;
             upper reference threshold, sodium &gt; 165 mmol/l, intensive care unit (ICU) stay &gt; 7&#xD;
             days, steatosis &gt; 40%, CIT &gt; 12 h.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Donor age ≤18 years;&#xD;
&#xD;
          -  Donors after circulatory death (DCD) will be excluded, because Italian law requires 20&#xD;
             minutes of &quot;no touch period&quot; before death declaration, causing prolonged warm ischemia&#xD;
             and subsequent mandatory perfusion of the organ.&#xD;
&#xD;
          -  Split-liver recipients, liver transplantation (LT) for acute liver failure,&#xD;
             pre-emptive renal transplant, dual kidney transplantation, and patients with&#xD;
             intra-operative surgical complications before the organ implantation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matteo Ravaioli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bologna S.Orsola-Malpighi Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Matteo Ravaioli, PhD</last_name>
    <phone>0512144810</phone>
    <phone_ext>+39</phone_ext>
    <email>mrava1@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matteo Ravaioli, PhD</last_name>
      <phone>0512144810</phone>
      <email>mrava1@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Matteo Ravaioli, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>https://trapianti.sanita.it</url>
    <description>Sistema Informativo Trapianti (SIT)</description>
  </link>
  <reference>
    <citation>Belzer FO, Southard JH. Principles of solid-organ preservation by cold storage. Transplantation. 1988 Apr;45(4):673-6. doi: 10.1097/00007890-198804000-00001. No abstract available.</citation>
    <PMID>3282347</PMID>
  </reference>
  <reference>
    <citation>Tanrisev M, Hoscoskun C, Asci G, Sozbilen M, Firat O, Ertilav M, Ozkahya M, Toz H. Long-term outcome of kidney transplantation from elderly living and expanded criteria deceased donors. Ren Fail. 2015 Mar;37(2):249-53. doi: 10.3109/0886022X.2014.982488. Epub 2014 Dec 3.</citation>
    <PMID>25470081</PMID>
  </reference>
  <reference>
    <citation>Feng S, Goodrich NP, Bragg-Gresham JL, Dykstra DM, Punch JD, DebRoy MA, Greenstein SM, Merion RM. Characteristics associated with liver graft failure: the concept of a donor risk index. Am J Transplant. 2006 Apr;6(4):783-90. doi: 10.1111/j.1600-6143.2006.01242.x. Erratum In: Am J Transplant. 2018 Dec;18(12):3085.</citation>
    <PMID>16539636</PMID>
  </reference>
  <reference>
    <citation>Ravaioli M, Baldassare M, Vasuri F, Pasquinelli G, Laggetta M, Valente S, De Pace V, Neri F, Siniscalchi A, Zanfi C, Bertuzzo VR, Caraceni P, Trere D, Longobardi P, Pinna AD. Strategies to Restore Adenosine Triphosphate (ATP) Level After More than 20 Hours of Cold Ischemia Time in Human Marginal Kidney Grafts. Ann Transplant. 2018 Jan 12;23:34-44. doi: 10.12659/aot.905406.</citation>
    <PMID>29326416</PMID>
  </reference>
  <reference>
    <citation>Ravaioli M, De Pace V, Comai G, Busutti M, Del Gaudio M, Amaduzzi A, Cucchetti A, Siniscalchi A, La Manna G, D'Errico AAD, Pinna AD. Successful Dual Kidney Transplantation After Hypothermic Oxygenated Perfusion of Discarded Human Kidneys. Am J Case Rep. 2017 Sep 20;18:1009-1013. doi: 10.12659/ajcr.905377.</citation>
    <PMID>28928357</PMID>
  </reference>
  <reference>
    <citation>Kron P, Schlegel A, de Rougemont O, Oberkofler CE, Clavien PA, Dutkowski P. Short, Cool, and Well Oxygenated - HOPE for Kidney Transplantation in a Rodent Model. Ann Surg. 2016 Nov;264(5):815-822. doi: 10.1097/SLA.0000000000001766.</citation>
    <PMID>27584571</PMID>
  </reference>
  <reference>
    <citation>Schlegel A, Muller X, Dutkowski P. Hypothermic Machine Preservation of the Liver: State of the Art. Curr Transplant Rep. 2018;5(1):93-102. doi: 10.1007/s40472-018-0183-z. Epub 2018 Jan 22. Erratum In: Curr Transplant Rep. 2018;5(1):103.</citation>
    <PMID>29564206</PMID>
  </reference>
  <reference>
    <citation>Dutkowski P, Polak WG, Muiesan P, Schlegel A, Verhoeven CJ, Scalera I, DeOliveira ML, Kron P, Clavien PA. First Comparison of Hypothermic Oxygenated PErfusion Versus Static Cold Storage of Human Donation After Cardiac Death Liver Transplants: An International-matched Case Analysis. Ann Surg. 2015 Nov;262(5):764-70; discussion 770-1. doi: 10.1097/SLA.0000000000001473.</citation>
    <PMID>26583664</PMID>
  </reference>
  <reference>
    <citation>Port FK, Bragg-Gresham JL, Metzger RA, Dykstra DM, Gillespie BW, Young EW, Delmonico FL, Wynn JJ, Merion RM, Wolfe RA, Held PJ. Donor characteristics associated with reduced graft survival: an approach to expanding the pool of kidney donors. Transplantation. 2002 Nov 15;74(9):1281-6. doi: 10.1097/00007890-200211150-00014.</citation>
    <PMID>12451266</PMID>
  </reference>
  <reference>
    <citation>Attia M, Silva MA, Mirza DF. The marginal liver donor--an update. Transpl Int. 2008 Aug;21(8):713-24. doi: 10.1111/j.1432-2277.2008.00696.x. Epub 2008 May 19.</citation>
    <PMID>18492121</PMID>
  </reference>
  <reference>
    <citation>Ravaioli M, De Pace V, Comai G, Capelli I, Baraldi O, D'Errico A, Bertuzzo VR, Del Gaudio M, Zanfi C, D'Arcangelo GL, Cuna V, Siniscalchi A, Sangiorgi G, La Manna G. Preliminary experience of sequential use of normothermic and hypothermic oxygenated perfusion for donation after circulatory death kidney with warm ischemia time over the conventional criteria - a retrospective and observational study. Transpl Int. 2018 Nov;31(11):1233-1244. doi: 10.1111/tri.13311. Epub 2018 Jul 20.</citation>
    <PMID>29957863</PMID>
  </reference>
  <reference>
    <citation>Olthoff KM, Kulik L, Samstein B, Kaminski M, Abecassis M, Emond J, Shaked A, Christie JD. Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors. Liver Transpl. 2010 Aug;16(8):943-9. doi: 10.1002/lt.22091.</citation>
    <PMID>20677285</PMID>
  </reference>
  <reference>
    <citation>Agopian VG, Harlander-Locke MP, Markovic D, Dumronggittigule W, Xia V, Kaldas FM, Zarrinpar A, Yersiz H, Farmer DG, Hiatt JR, Busuttil RW. Evaluation of Early Allograft Function Using the Liver Graft Assessment Following Transplantation Risk Score Model. JAMA Surg. 2018 May 1;153(5):436-444. doi: 10.1001/jamasurg.2017.5040. Erratum In: JAMA Surg. 2018 May 1;153(5):498.</citation>
    <PMID>29261831</PMID>
  </reference>
  <reference>
    <citation>Humar A, Ramcharan T, Kandaswamy R, Gillingham K, Payne WD, Matas AJ. Risk factors for slow graft function after kidney transplants: a multivariate analysis. Clin Transplant. 2002 Dec;16(6):425-9. doi: 10.1034/j.1399-0012.2002.02055.x.</citation>
    <PMID>12437622</PMID>
  </reference>
  <reference>
    <citation>Schlegel A, de Rougemont O, Graf R, Clavien PA, Dutkowski P. Protective mechanisms of end-ischemic cold machine perfusion in DCD liver grafts. J Hepatol. 2013 Feb;58(2):278-86. doi: 10.1016/j.jhep.2012.10.004. Epub 2012 Oct 11.</citation>
    <PMID>23063573</PMID>
  </reference>
  <reference>
    <citation>Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.</citation>
    <PMID>19845597</PMID>
  </reference>
  <results_reference>
    <citation>Versteilen AM, Di Maggio F, Leemreis JR, Groeneveld AB, Musters RJ, Sipkema P. Molecular mechanisms of acute renal failure following ischemia/reperfusion. Int J Artif Organs. 2004 Dec;27(12):1019-29. doi: 10.1177/039139880402701203.</citation>
    <PMID>15645611</PMID>
  </results_reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bologna</investigator_affiliation>
    <investigator_full_name>Matteo Ravaioli, MD</investigator_full_name>
    <investigator_title>Principal Investigator, General Manager of General Surgery</investigator_title>
  </responsible_party>
  <keyword>donors and donation</keyword>
  <keyword>Extended criteria donor</keyword>
  <keyword>Organ perfusion and preservation</keyword>
  <keyword>Liver transplantation</keyword>
  <keyword>Kidney transplantation</keyword>
  <keyword>Preservation injury</keyword>
  <keyword>Ischemia reperfusion injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03837197
org study id: RF-2016-02364732
nct id: NCT03837197
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
With the present study the investigators will evaluate the benefit of end-ischemic HOPE on
      ECD grafts (livers and kidneys) as compared to SCS. Organs will be perfused through a
      recently developed machine perfusion (MP) device, from the beginning of back-table procedures
      till implantation, without increasing CIT. The aim of the study will be demonstrating the
      ability of HOPE to improve graft function and post-operative outcomes of ECD kidney and liver
      recipients.
Extended criteria donors (ECD) are widely utilized due to organ shortage, but this may
      increase the risk of graft dysfunction and of poorer outcomes.

      Hypothermic oxygenated perfusion (HOPE) is a recent organ preservation strategy for marginal
      kidney and liver grafts, which allows to redirect anaerobic metabolism to aerobic metabolism
      under hypothermic conditions and to protect grafts from oxidative species-related damage;
      these mechanisms may potentially improve graft function and survival.

      Methods This is an open-label, randomized multicenter clinical trial with the aim of
      comparing HOPE vs. static cold storage (SCS) in ECD kidney and liver transplantation.

      In the study protocol - approved by ethics committee - 220 patients (110 liver recipients and
      110 kidney recipients) will be enrolled. Livers and kidneys assigned to HOPE will be perfused
      by machine perfusion with cold Belzer solution (4°-10°C) and with continuous oxygenation
      (partial pressure of oxygen = 500-600 mmHg). In the control group, livers and kidneys
      undergoing SCS will be steeped in Celsior or University of Wisconsin Belzer solutions and
      stored in ice. Using the same perfusion machine for both liver and kidney grafts, organs will
      be perfused from the start of the back-table procedure until implantation, without increasing
      cold ischemia time (CIT). For each group the investigators will evaluate clinical outcomes,
      graft function tests and histologic findings, as well as perfusate and the number of
      allocated organs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Liver Transplant - Early allograft dysfunction (EAD)
time frame: 0-30 days after procedure
description: Present/Non present
measure: Kidney Transplant- Delayed graft function (DGF)
time frame: 0-30 days after procedure
description: Present/Non present
measure: Liver and Kidney surgical complications
time frame: 0-6 months after procedure
description: Present/Non present
measure: Liver and Kidney graft function at 6 and 12 months
time frame: 0-12 months after procedure
description: Functioning/non functioning
measure: Patient survival at 6 and 12 months
time frame: 0-12 months after procedure
description: Alive/Death
arm group label: Kidney-Hypothermic oxygenated
arm group type: Experimental
description: Belzer machine perfusion solution at 4°C-10°C in sterile conditions and continuous oxygenation (partial pressure of oxygen=500-600 mmHg) will be used for perfusion 2000 ml for kidneys.
arm group label: Kidney-Static Cold Storage
arm group type: No Intervention
description: Kidneys undergoing SCS will be stored in sterile organ bags with Celsior or University of Wisconsin solution and cooled in ice.
arm group label: Liver-Hypothermic oxygenated
arm group type: Experimental
description: Belzer machine perfusion solution at 4°C-10°C in sterile conditions and continuous oxygenation (partial pressure of oxygen=500-600 mmHg) will be used for perfusion 3000 ml for livers.
arm group label: Liver-Static Cold Storage
arm group type: No Intervention
description: Livers undergoing SCS will be stored in sterile organ bags with Celsior or University of Wisconsin solution and cooled in ice.
intervention type: Device
intervention name: Kidney-Hypothermic oxygenated
description: Kidney perfusion will be performed through the renal artery at 25-30 mmHg pressure.
Flow, pressure and temperature will be monitored and registered on a Universal Serial Bus (USB) memory system during organ perfusion. Gas analysis of the effluent perfusate will be accomplished at the start of perfusion (T0) then every 30 minutes. Two perfusate samples will be collected at the beginning and at the end of perfusion to rule out bacterial or fungal contamination.
HOPE will start by flushing the organ at low flow values (20 ml/min) with new oxygenated perfusion fluid during back-table preparation. Organ will be treated with continuous HOPE until transplant. Organ perfusion will be continuously monitored. Minimal perfusion time will be 2 hours for kidneys.
arm group label: Kidney-Hypothermic oxygenated
intervention type: Device
intervention name: Liver-Hypothermic oxygenated
description: Liver perfusion will be performed through the portal vein at a 5 mmHg pressure.
Flow, pressure and temperature will be monitored and registered on a Universal Serial Bus (USB) memory system during organ perfusion. Gas analysis of the effluent perfusate will be accomplished at the start of perfusion (T0) then every 30 minutes. Two perfusate samples will be collected at the beginning and at the end of perfusion to rule out bacterial or fungal contamination.
HOPE will start by flushing the organ at low flow values (30 ml/min) with new oxygenated perfusion fluid during back-table preparation. Organ will be treated with continuous HOPE until transplant. Organ perfusion will be continuously monitored. Minimal perfusion time will be 1 hour for livers.
arm group label: Liver-Hypothermic oxygenated
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Matteo Ravaioli, PhD
role: Principal Investigator
affiliation: University of Bologna S.Orsola-Malpighi Hospital
last name: Matteo Ravaioli, PhD
phone: 0512144810
phone ext: +39
email: mrava1@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
url: https://trapianti.sanita.it
description: Sistema Informativo Trapianti (SIT)
citation: Belzer FO, Southard JH. Principles of solid-organ preservation by cold storage. Transplantation. 1988 Apr;45(4):673-6. doi: 10.1097/00007890-198804000-00001. No abstract available.
PMID: 3282347
citation: Tanrisev M, Hoscoskun C, Asci G, Sozbilen M, Firat O, Ertilav M, Ozkahya M, Toz H. Long-term outcome of kidney transplantation from elderly living and expanded criteria deceased donors. Ren Fail. 2015 Mar;37(2):249-53. doi: 10.3109/0886022X.2014.982488. Epub 2014 Dec 3.
PMID: 25470081
citation: Feng S, Goodrich NP, Bragg-Gresham JL, Dykstra DM, Punch JD, DebRoy MA, Greenstein SM, Merion RM. Characteristics associated with liver graft failure: the concept of a donor risk index. Am J Transplant. 2006 Apr;6(4):783-90. doi: 10.1111/j.1600-6143.2006.01242.x. Erratum In: Am J Transplant. 2018 Dec;18(12):3085.
PMID: 16539636
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responsible party type: Principal Investigator
investigator affiliation: University of Bologna
investigator full name: Matteo Ravaioli, MD
investigator title: Principal Investigator, General Manager of General Surgery
mesh term: Liver Diseases
mesh term: Kidney Diseases