Ischemic Reperfusion InjuryCEFEMANCT02940600
Efficacy Evaluation of Normothermic Perfusion Machine Preservation in Liver Transplant Using Very Old Donors
A study testing Normothermic machine perfusion and Static cold storage in people with Ischemic Reperfusion Injury, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the impact of normothermic machine perfusion in liver transplantation using grafts of brain death donors older or equal than 70 years Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ischemic Reperfusion Injury
- What is being tested?
- Normothermic machine perfusion and Static cold storage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2016to Oct 2018
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient on waiting list for liver transplant
- Signed informed consent
- Age between 18 and 70
- Eligibility for liver transplant as for University of Pisa Liver Transplant Center Protocol
- Capacity and willingness to participate to the protocol
Who cannot join
- No signed informed consent
- Age under 18 or over 70
- Presence of disease that may influence results
- Patient participation to other studies
- Re-liver transplant
- ABO incompatible OLT
Show all 10Show fewer
- Multiorgan transplant
- Liver transplant for acute liver failure or trauma
- MELD (model for end stage liver disease) >24
- Patient not suitable to participate on investigators's opinion
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
UO Chirurgia Epatica e del Trapianto di Fegato
Pisa, Pisa, 56124
Davide Ghinolfi, MD, +39050995421, d.ghinolfi@ao-pisa.toscana.it
Daniele Pezzati, MD, +393202172957, danypez@hotmail.it
About this study
Official title: Pilot, Open, Monocentric, Randomized, Prospective Trial for the Evaluation of the Efficacy of Normothermic Perfusion Machine for Organ Preservation in Liver Transplantation Using Brain Death Donors Older or Equal Than 70 Years
The purpose of this study is to evaluate the impact of normothermic machine perfusion in liver transplantation using grafts of brain death donors older or equal than 70 years
Read the detailed description
Mean donor age for liver transplantation in Tuscany, Italy, is increasing and is actually 71 years. Old donors are a valuable resource but their use has been related to a major incidence of primary non function (PNF), delayed graft function (DGF) and ischemic type biliary lesions (ITBL).
Ischemia-reperfusion injury is a major reason for the development of these complications and and old grafts are more susceptible than younger ones.
Normothermic machine perfusion (NMP) is a novel and promising technique that allows preservation in a more physiological environment. It is our belief that the use of NMP might reduce the impact of ischemia-reperfusion injuries in older grafts thus reducing the incidence of complications and providing a better outcome.
- Conditions
- Ischemic Reperfusion Injury
- Being tested
- Normothermic machine perfusion, Static cold storage
- Keywords
- normothermic perfusion, old donors, extended criteria grafts, reconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normothermic machine perfusionDevice
Also called Liver Assist
Patients undergoing liver transplant with the use of grafts preserved with normothermic perfusion machine
Static cold storageProcedure or surgery
Patients undergoing liver transplant using statically cold preserved grafts
| Study group | Role | What they receive |
|---|---|---|
| Normothermic machine perfusion | Experimental | Patients undergoing liver transplant with grafts preserved using normothermic machine perfusion Receives: Device: Normothermic machine perfusion |
| Static cold storage | Active comparator | Patients undergoing liver transplant with statically cold preserved grafts Receives: Procedure: Static cold storage |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 months graft survival
Measured: 180 days
Secondary outcomes (3)
Ischemia-reperfusion injury assessment through biopsies evaluation
Measured: 1 day
ischemia reperfusion injury assessment through transaminases
AST level at post operative day number 7
Measured: 7 days
Ischemia reperfusion injury assessment through incidence of ischemic type biliary lesions
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemic Reperfusion InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Ghinolfi, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Davide Ghinolfi, MD, PhD, Principal investigator, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940600
- Sponsor's protocol ID
- 687
- Acronym
- CEFEMA
- Status last verified
- Oct 2016
- First submitted
- 16 Oct 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bral M, Gala-Lopez B, Bigam D, Kneteman N, Malcolm A, Livingstone S, Andres A, Emamaullee J, Russell L, Coussios C, West LJ, Friend PJ, Shapiro AM. Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion: Results of a Clinical Trial. Am J Transplant. 2017 Apr;17(4):1071-1080. doi: 10.1111/ajt.14049. Epub 2016 Dec 9.
PubMed 27639262Mergental H, Perera MT, Laing RW, Muiesan P, Isaac JR, Smith A, Stephenson BT, Cilliers H, Neil DA, Hubscher SG, Afford SC, Mirza DF. Transplantation of Declined Liver Allografts Following Normothermic Ex-Situ Evaluation. Am J Transplant. 2016 Nov;16(11):3235-3245. doi: 10.1111/ajt.13875. Epub 2016 Jul 13.
PubMed 27192971Op den Dries S, Karimian N, Westerkamp AC, Sutton ME, Kuipers M, Wiersema-Buist J, Ottens PJ, Kuipers J, Giepmans BN, Leuvenink HG, Lisman T, Porte RJ. Normothermic machine perfusion reduces bile duct injury and improves biliary epithelial function in rat donor livers. Liver Transpl. 2016 Jul;22(7):994-1005. doi: 10.1002/lt.24436.
PubMed 26946466Ravikumar R, Jassem W, Mergental H, Heaton N, Mirza D, Perera MT, Quaglia A, Holroyd D, Vogel T, Coussios CC, Friend PJ. Liver Transplantation After Ex Vivo Normothermic Machine Preservation: A Phase 1 (First-in-Man) Clinical Trial. Am J Transplant. 2016 Jun;16(6):1779-87. doi: 10.1111/ajt.13708. Epub 2016 Mar 7.
PubMed 26752191
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Open, Monocentric, Randomized, Prospective Trial for the Evaluation of the Efficacy of Normothermic Perfusion Machine for Organ Preservation in Liver Transplantation Using Brain Death Donors Older or Equal Than 70 Years
- ClinicalTrials.gov ID
- NCT02940600
- Acronym / sponsor ID
- CEFEMA / 687
- Conditions
- Ischemic Reperfusion Injury
- Keywords
- normothermic perfusion, old donors, extended criteria grafts, reconditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 21 Oct 2016 (estimated)
- 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.
The purpose of this study is to evaluate the impact of normothermic machine perfusion in liver transplantation using grafts of brain death donors older or equal than 70 years
Detailed description
Mean donor age for liver transplantation in Tuscany, Italy, is increasing and is actually 71 years. Old donors are a valuable resource but their use has been related to a major incidence of primary non function (PNF), delayed graft function (DGF) and ischemic type biliary lesions (ITBL).
Ischemia-reperfusion injury is a major reason for the development of these complications and and old grafts are more susceptible than younger ones.
Normothermic machine perfusion (NMP) is a novel and promising technique that allows preservation in a more physiological environment. It is our belief that the use of NMP might reduce the impact of ischemia-reperfusion injuries in older grafts thus reducing the incidence of complications and providing a better outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normothermic machine perfusion | Experimental | Device: Normothermic machine perfusionPatients undergoing liver transplant with grafts preserved using normothermic machine perfusion |
| Static cold storage | Active comparator | Procedure: Static cold storagePatients undergoing liver transplant with statically cold preserved grafts |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient on waiting list for liver transplant
- Signed informed consent
- Age between 18 and 70
- Eligibility for liver transplant as for University of Pisa Liver Transplant Center Protocol
- Capacity and willingness to participate to the protocol
Key exclusion criteria (10 listed)
- No signed informed consent
- Age under 18 or over 70
- Presence of disease that may influence results
- Patient participation to other studies
- Re-liver transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normothermic machine perfusionAlso: Liver AssistPatients undergoing liver transplant with the use of grafts preserved with normothermic perfusion machine | Device | Normothermic machine perfusion |
| Static cold storagePatients undergoing liver transplant using statically cold preserved grafts | Procedure or surgery | Static cold storage |
Primary outcome
6 months graft survival
Time frame: 180 days
3 secondary outcomes
Ischemia-reperfusion injury assessment through biopsies evaluation
Time frame: 1 day
ischemia reperfusion injury assessment through transaminases
Time frame: 7 days
Ischemia reperfusion injury assessment through incidence of ischemic type biliary lesions
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Background: PubMed 27639262Bral M, Gala-Lopez B, Bigam D, Kneteman N, Malcolm A, Livingstone S, Andres A, Emamaullee J, Russell L, Coussios C, West LJ, Friend PJ, Shapiro AM. Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion: Results of a Clinical Trial. Am J Transplant. 2017 Apr;17(4):1071-1080. doi: 10.1111/ajt.14049. Epub 2016 Dec 9.
- Background: PubMed 27192971Mergental H, Perera MT, Laing RW, Muiesan P, Isaac JR, Smith A, Stephenson BT, Cilliers H, Neil DA, Hubscher SG, Afford SC, Mirza DF. Transplantation of Declined Liver Allografts Following Normothermic Ex-Situ Evaluation. Am J Transplant. 2016 Nov;16(11):3235-3245. doi: 10.1111/ajt.13875. Epub 2016 Jul 13.
- Background: PubMed 26946466Op den Dries S, Karimian N, Westerkamp AC, Sutton ME, Kuipers M, Wiersema-Buist J, Ottens PJ, Kuipers J, Giepmans BN, Leuvenink HG, Lisman T, Porte RJ. Normothermic machine perfusion reduces bile duct injury and improves biliary epithelial function in rat donor livers. Liver Transpl. 2016 Jul;22(7):994-1005. doi: 10.1002/lt.24436.
- Background: PubMed 26752191Ravikumar R, Jassem W, Mergental H, Heaton N, Mirza D, Perera MT, Quaglia A, Holroyd D, Vogel T, Coussios CC, Friend PJ. Liver Transplantation After Ex Vivo Normothermic Machine Preservation: A Phase 1 (First-in-Man) Clinical Trial. Am J Transplant. 2016 Jun;16(6):1779-87. doi: 10.1111/ajt.13708. Epub 2016 Mar 7.
- 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.
Davide Ghinolfi, MD, PhD principal investigator
Azienda Ospedaliero, Universitaria Pisana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normothermic machine perfusion and Static cold storage in people with Ischemic Reperfusion Injury, run by Azienda Ospedaliero, Universitaria Pisana 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?
The sponsor lists 5 inclusion and 10 exclusion criteria. 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 21 Oct 2016. 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 Davide Ghinolfi, MD, PhD (+39050995421, d.ghinolfi@ao-pisa.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 months graft survival (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02940600, which also lists 4 linked publications.
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 21 Oct 2016.