NCT03031067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

January 19, 2017

Last Update Submit

February 12, 2018

Conditions

Kidney DiseasesLiver Diseases

Keywords

Donors and donationExtended criteria donorOrgan perfusion and preservationLiver transplantationKidney transplantationPreservation injuryIschemia reperfusion injury

Outcome Measures

Primary Outcomes (1)

  • Graft function

    Physiological values of serum creatinine and diuresis for kidney transplantation and bilirubin, AST, ALT, INR for liver transplantation

    3 months post-transplantation (+18/-2 months)

Secondary Outcomes (4)

  • Graft survival - Kidney

    3 months post-transplantation (+18/-2 months)

  • Graft survival - Liver

    3 months post-transplantation (+18/-2 months)

  • Patient survival (kidney recipient)

    3 months post-transplantation (+18/-2 months)

  • Patient survival (liver recipient)

    3 months post-transplantation (+18/-2 months)

Study Arms (4)

Machine perfusion - Kidney

EXPERIMENTAL

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

Static cold storage - Kidney

NO INTERVENTION

The marginal kidney that was stored to cold (SCS), previously.

Machine perfusion - Liver

EXPERIMENTAL

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

Static cold storage - Liver

NO INTERVENTION

The marginal liver that was stored to cold (SCS), previously.

Interventions

Machine perfusionDEVICE

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.

Also known as: Hypothermic Oxygenated Perfusion
Machine perfusion - KidneyMachine perfusion - Liver

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

Bologna, 40138, Italy

Location

Related Publications (4)

  • O'Callaghan JM, Morgan RD, Knight SR, Morris PJ. Systematic review and meta-analysis of hypothermic machine perfusion versus static cold storage of kidney allografts on transplant outcomes. Br J Surg. 2013 Jul;100(8):991-1001. doi: 10.1002/bjs.9169.

    PMID: 23754643BACKGROUND

  • Thuillier R, Allain G, Celhay O, Hebrard W, Barrou B, Badet L, Leuvenink H, Hauet T. Benefits of active oxygenation during hypothermic machine perfusion of kidneys in a preclinical model of deceased after cardiac death donors. J Surg Res. 2013 Oct;184(2):1174-81. doi: 10.1016/j.jss.2013.04.071. Epub 2013 May 21.

    PMID: 23731682BACKGROUND

  • Hosgood SA, Nicholson HF, Nicholson ML. Oxygenated kidney preservation techniques. Transplantation. 2012 Mar 15;93(5):455-9. doi: 10.1097/TP.0b013e3182412b34.

    PMID: 22217529BACKGROUND

  • 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.

    PMID: 26583664BACKGROUND

MeSH Terms

Conditions

Liver DiseasesKidney DiseasesReperfusion Injury

Condition Hierarchy (Ancestors)

Digestive System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matteo Ravaioli, PhD

    University of Bologna S. Orsola-Malpighi Hospital, Transplantation and General Surgery Unit

    PRINCIPAL INVESTIGATOR

  • Antonio Daniele Pinna, Professor

    University of Bologna S. Orsola-Malpighi Hospital, Transplantation and General Surgery Unit

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2017

First Posted

January 25, 2017

Study Start

October 1, 2016

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

February 13, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Individual participant data will be performed by application of a single code.

Locations

IT(1)