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

NCT03098043 | Unknown

• 1 other identifier: Post-SCS Liver HOPE Bg
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation

Keywords

Hypothermic machine perfusion; Donation after circulatory death; Extended criteria liver grafts

Outcome Measures

Primary Outcomes (1)

• Incidence of early allograft dysfunction (safety endpoint)

  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

  Post-operative day 7

Secondary Outcomes (7)

• Rate of complications grade ≥IIIa

  1 year after transplantation

• Incidence of ischemic cholangiopathy

  6 months after transplantation

• Length of intensive care unit and hospital stay

  1 year after transplantation

• 30-day patient survival

  Post-operative day 30

• 30-day graft survival

  Post-operative day 30

Eligibility Criteria

• Age: 30 Days - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

Papa Giovanni XXIII Hospital

Bergamo, 24127, Italy

RECRUITING

Study Officials

• Stefania Camagni, MD

  Papa Giovanni XXIII Hospital

  PRINCIPAL INVESTIGATOR

• Michele Colledan, MD

  Papa Giovanni XXIII Hospital

  STUDY DIRECTOR

Central Study Contacts

Stefania Camagni, MD

CONTACT

00390352674347; scamagni@asst-pg23.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 26, 2017
• First Posted: March 31, 2017
• Study Start: November 5, 2017
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)