Liver TransplantationNCT03098043
Post-Static Cold Storage Hypothermic Oxygenated Perfusion in Bergamo Liver Transplant Program
An observational study of Liver Transplantation, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 days to 70 years
- Conditions the study is for
- Liver Transplantation
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 5 Nov 2017to 3 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 days to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Papa Giovanni XXIII Hospital
Bergamo, 24127
Stefania Camagni, MD, 00390352674347, scamagni@asst-pg23.it
About this study
Official title: Post-Static Cold Storage Hypothermic Oxygenated Perfusion in Bergamo Liver Transplant Program: a Prospective Observational Study
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.
Read more
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.
Read the 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.
- Conditions
- Liver Transplantation
- Keywords
- Hypothermic machine perfusion, Donation after circulatory death, Extended criteria liver grafts
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Post-operative day 7
Secondary outcomes (7)
Rate of complications grade ≥IIIa
Dindo-Clavien classification of surgical complications
Measured: 1 year after transplantation
Incidence of ischemic cholangiopathy
Radiological or endoscopic diagnosis of unifocal or multifocal intrahepatic strictures in the absence of any arterial complication
Measured: 6 months after transplantation
Length of intensive care unit and hospital stay
Length of intensive care unit and hospital stay after transplantation (days)
Measured: 1 year after transplantation
30-day patient survival
Patient survival rate 30 days after transplantation
Measured: Post-operative day 30
30-day graft survival
Graft survival rate 30 days after transplantation
Measured: Post-operative day 30
1-year patient survival
Patient survival rate 1 year after transplantation
Measured: 1 year after transplantation
1-year graft survival
Graft survival rate 1 year after transplantation
Measured: 1 year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start5 Nov 2017
- Primary completion3 Dec 2021 (estimated)
- Study completion3 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania Camagni, Papa Giovanni XXIII Hospital
- Investigators
- Stefania Camagni, MD, Principal investigator, Papa Giovanni XXIII HospitalMichele Colledan, MD, Study director, Papa Giovanni XXIII Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098043
- Sponsor's protocol ID
- Post-SCS Liver HOPE Bg
- Status last verified
- Nov 2019
- First submitted
- 26 Mar 2017
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Static Cold Storage Hypothermic Oxygenated Perfusion in Bergamo Liver Transplant Program: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03098043
- Acronym / sponsor ID
- Post-SCS Liver HOPE Bg
- Conditions
- Liver Transplantation
- Keywords
- Hypothermic machine perfusion, Donation after circulatory death, Extended criteria liver grafts
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- 5 Nov 2017 (actual)
- Primary completion
- 3 Dec 2021 (estimated)
- Study completion
- 3 Dec 2021 (estimated)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 days to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Rate of complications grade ≥IIIa
Time frame: 1 year after transplantation
Incidence of ischemic cholangiopathy
Time frame: 6 months after transplantation
Length of intensive care unit and hospital stay
Time frame: 1 year after transplantation
30-day patient survival
Time frame: Post-operative day 30
30-day graft survival
Time frame: Post-operative day 30
1-year patient survival
Time frame: 1 year after transplantation
1-year graft survival
Time frame: 1 year after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefania Camagni, MD principal investigator
Papa Giovanni XXIII Hospital
Michele Colledan, MD study director
Papa Giovanni XXIII Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefania Camagni, MD (00390352674347, scamagni@asst-pg23.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of early allograft dysfunction (safety endpoint) (time frame: Post-operative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.