Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-Static Cold Storage Hypothermic Oxygenated Perfusion in Bergamo Liver Transplant Program

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03098043
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Stefania Camagni, Papa Giovanni XXIII Hospital

Brief Summary:

In light of the widespread organ shortage, dynamic preservation by means of Machine Perfusion (MP) has been proposed as a strategy to increase the pool of suitable grafts for liver transplantation. Reproducing more physiological conditions than traditional Static Cold Storage (SCS), MP may allow a better preservation and evaluation and perhaps even the resuscitation of high risk grafts. As a consequence, unnecessary discard of organs could be avoided and quality and safety of transplantation could be improved as well.

Hypothermic MP (HMP) seems to reduce ischemia-reperfusion injury. In fact, hypothermia slows down the metabolic rate and the oxygenation of the perfusate leads to re-synthesis of Adenosine TriPhosphate (ATP), which results in the restoration of cellular energy.

Four series about the use of HMP in the clinical setting has been published so far. They all report acceptable outcomes after transplantation of human liver grafts from extended criteria Brain Dead Donors (BDD) and from Donation after Circulatory Death (DCD) donors preserved by HMP, thus proving its feasibility and safety. The efficacy of HMP, instead, is still under investigation in a phase II randomized trial.

This is an observational, prospective, monocentric study aiming at verifying the feasibility and safety of post-SCS Hypothermic Oxygenated PErfusion (HOPE) in the setting of our liver transplant program. Extended criteria grafts from BDD and grafts from DCD donors will be preserved by post-SCS HOPE prior to transplantation. The recipients of these grafts will be followed-up for at least 1 year.


Condition or disease
Liver Transplantation

Detailed Description:

This is an observational, prospective, monocentric study aiming at verifying the feasibility and safety of post-SCS HOPE in the setting of our liver transplant program.

20 consecutive patients with written informed consent will be enrolled. They will be transplanted with grafts from extended criteria BDD or from DCD donors preserved by post-SCS HOPE.

The HOPE procedure will be performed in our operating room after regular procurement, transport and back-table preparation. University of Wisconsin Machine Perfusion Solution (UW-MPS) will be used. Two pumps will provide dual pressure-controlled perfusion through the portal vein and the hepatic artery. Portal flow will be continuous and will be adjusted to keep portal pressure below 5 mmHg. Instead, arterial flow will be pulsatile and will be regulated to maintain arterial pressure between 25 mmHg and 30 mmHg. The perfusate will be oxygenated with the goal of a partial Pressure of Oxygen (PO2) of 50-70 kilopascal. The perfusate temperature will be kept between 4°C and 12°C by a heat exchanger. pH, PO2 and partial Pressure of Carbon Dioxide (PCO2) of the perfusate pumped to the graft and drained from the vena cava will be monitored. HOPE will be maintained for 3 to 4 hours.

Patients will be followed-up for at least 1 year according to a scheduled timetable.

Data about HOPE and transplant procedure, about donors and recipients' characteristics and about patients' follow-up will be collected in a dedicated electronic Case Report Form (eCRF) according to Good Clinical Practice.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Static Cold Storage Hypothermic Oxygenated Perfusion in Bergamo Liver Transplant Program: a Prospective Observational Study
Actual Study Start Date : November 5, 2017
Estimated Primary Completion Date : April 3, 2020
Estimated Study Completion Date : April 3, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of early allograft dysfunction (safety endpoint) [ Time Frame: Post-operative day 7 ]
    Occurrence of one or more of the following: bilirubin >170 µmol/L on Post-Operative Day (POD) 7, International Normalized Ratio (INR) >1,6 on POD 7, Alanine AminoTransferase (ALT) peak >2000 U/L within the first post-operative week


Secondary Outcome Measures :
  1. Rate of complications grade ≥IIIa [ Time Frame: 1 year after transplantation ]
    Dindo-Clavien classification of surgical complications

  2. Incidence of ischemic cholangiopathy [ Time Frame: 6 months after transplantation ]
    Radiological or endoscopic diagnosis of unifocal or multifocal intrahepatic strictures in the absence of any arterial complication

  3. Length of intensive care unit and hospital stay [ Time Frame: 1 year after transplantation ]
    Length of intensive care unit and hospital stay after transplantation (days)

  4. 30-day patient survival [ Time Frame: Post-operative day 30 ]
    Patient survival rate 30 days after transplantation

  5. 30-day graft survival [ Time Frame: Post-operative day 30 ]
    Graft survival rate 30 days after transplantation

  6. 1-year patient survival [ Time Frame: 1 year after transplantation ]
    Patient survival rate 1 year after transplantation

  7. 1-year graft survival [ Time Frame: 1 year after transplantation ]
    Graft survival rate 1 year after transplantation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All the patients on the waiting list for liver transplantation at Bergamo transplant centre, except for those who are candidates to combined en bloc liver and pancreas transplantation
Criteria

Grafts inclusion criteria:

  • extended criteria BDD with a mix of the following: age ≥70 years, liver macrosteatosis ≥35%, anti-Hepatitis C Virus (HCV) positivity, Hepatitis B surface Antigen (HBsAg) positivity, hemodynamic instability
  • DCD donors category IVB (on ExtraCorporeal Membrane Oxygenation (ECMO) support) with a mix of the above-mentioned characteristics and/or with undetermined hepatocellular necrosis
  • DCD donors category I-IVA on normothermic regional ECMO support
  • different donors characteristics from the above-mentioned ones but organisational set-up including prolonged total ischemic time.

Grafts exclusion criteria: living donors.

Recipients' inclusion criteria:

  • liver transplant candidates who are going to be transplanted with a graft preserved by post-SCS HOPE
  • liver transplant candidates who consent to participate in the study by signing the informed consent form.

Recipients' exclusion criteria:

  • liver transplant candidates who are going to be transplanted with a graft preserved by SCS
  • liver transplant candidates who are going to be transplanted with a graft preserved by post-SCS HOPE but refuse consent for their participation in the study.

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): NCT03098043


Contacts
Layout table for location contacts
Contact: Stefania Camagni, MD 00390352674347 scamagni@asst-pg23.it

Locations
Layout table for location information
Italy
Papa Giovanni XXIII Hospital Recruiting
Bergamo, Italy, 24127
Contact: Stefania Camagni, MD    00390352674347    scamagni@asst-pg23.it   
Sponsors and Collaborators
Papa Giovanni XXIII Hospital
Investigators
Layout table for investigator information
Principal Investigator: Stefania Camagni, MD Papa Giovanni XXIII Hospital
Study Director: Michele Colledan, MD Papa Giovanni XXIII Hospital

Layout table for additonal information
Responsible Party: Stefania Camagni, MD, Papa Giovanni XXIII Hospital
ClinicalTrials.gov Identifier: NCT03098043     History of Changes
Other Study ID Numbers: Post-SCS Liver HOPE Bg
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stefania Camagni, Papa Giovanni XXIII Hospital:
Hypothermic machine perfusion
Donation after circulatory death
Extended criteria liver grafts

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypothermia
Body Temperature Changes
Signs and Symptoms