Liver Transplantation (LT)ARANMP-LTNCT07692490
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
A study testing No Recooling Before Liver Implantation and Traditional Recooling Before Liver Implantation in people with Liver Transplantation (LT) and Ischemia-Reperfusion Injury, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies at 14 sites in Italy.
Trial summary
The ARANMP-LT study is a multicenter, open-label, randomized, parallel-group, non-inferiority clinical trial designed to evaluate whether avoiding graft recooling after normothermic machine perfusion (NMP) improves early outcomes following liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation (LT), Ischemia-Reperfusion Injury, Early Allograft Dysfunction
- What is being tested?
- No Recooling Before Liver Implantation and Traditional Recooling Before Liver Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 14 sitesItaly
- Study dates
- 7 Jul 2026to 6 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Listed for primary liver transplantation at the participating institution.
- Assigned a liver graft preserved with normothermic machine perfusion or sequential hypothermic- normothermic machine perfusion (SHNMP).
- Signed and dated informed consent prior study inclusion.
Who cannot join
- Pediatric patients (age < 18 years)
- Patients undergoing re-transplantation (history of previous liver transplantation)
- Patients with acute liver failure
- Patients undergoing multi-organ transplantation (e.g., liver-kidney, liver-heart)
- Temporarily unconscious patients
- Patients unable to freely express consent.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Italy14 sites, 14 recruiting
- Not yet recruiting
Università Politecnica delle Marche, AUO delle Marche
Ancona, 60126
Marco Vivarelli, vivarelli63@libero.it
Federico Mocchegiani, federicomocchegiani@hotmail.com
- Not yet recruiting
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari - Ospedale Giovanni XXIII
Bari, 70124
Francesco Tandoi, francesco.tandoi@uniba.it
Irene Scalera, irenescalera@gmail.com
- Not yet recruiting
ASST Papa Giovanni XXIII
Bergamo, 24127
Stefania Camagni, scamagni@asst-pg23.it
Trial Clinici Coordinamento, ctc@asst-pg23.it
- Not yet recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Matteo Cescon, 0512144785 ext. +39 0512144785, matteo.cescon@unibo.it
Matteo Serenari, 0512145276 ext. +39 0512145276, matteo.serenari@gmail.com
- Not yet recruiting
Ospedale Università Policlinico San Martino - IRCCS
Genova, 16132
Enzo Andorno, enzo.andorno@hsanmartino.it
Marco Miggino, 0105555850 ext. +39 0105555850, marco.miggino@hsanmartino.it
- Not yet recruiting
Università di Modena e Reggio Emilia
Modena, 41124
Fabrizio Di Benedetto, fabrizio.dibenedetto@unimore.it
Paolo Magistri, 059 422 5178 ext. +39 0594225178, paolo.magistri@unimore.it
- Not yet recruiting
Azienda Ospedale-Università di Padova
Padova, 35128
Umberto Cillo, 049 821 1846 ext. +39 0498211846, cillo@unipd.it
Jacopo Lanari, 049 821 8601 ext. +39 0498218601, jacopo.lanari@unipd.it
- Recruiting
IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
Palermo, 90127
Salvatore Gruttadauria, +39 0912192618 ext. +39 0912192618, sgruttadauria@ismett.edu
Monica Rizzo, +39 0912192692 ext. +39 0912192692, morizzo@ismett.edu
- Not yet recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Davide Ghinolfi, d.ghinolfi@ao-pisa.toscana.it
Giulia Cirillo, giulia.cirillo@ao-pisa.toscana.it
- Not yet recruiting
Fondazione PTV - Policlinico Tor Vergata
Roma, 00133
Giuseppe Tisone, tisone@uniroma2.it
Roberta Angelico, Roberta.angelico@uniroma2.it
- Not yet recruiting
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152
Giuseppe Maria Ettorre, 06 58704816 ext. +39 0658704816, gmettorre@scamilloforlanini.rm.it
Sara Ingallinella, sara.ingallinella@gmail.com
- Not yet recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I - Sapienza Università di Roma
Roma, 00161
Fabio Melandro, fabio.melandro@uniroma1.it
Gianluca Mennini
- Not yet recruiting
Fondazione Policlinico "Agostino Gemelli" IRCCS
Roma, 00168
Francesco Frongillo, francesco.frongillo@policlinicogemelli.it
Marco Maria Pascale, marcomaria.pascale@policlinicogemelli.it
- Not yet recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Amedeo Carraro, amedeo.carraro@aovr.veneto.it
Alex Borin
About this study
Official title: Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation: a Multicenter, Parallel-group, Open-label, Non-inferiority Randomized Controlled Trial
The ARANMP-LT study is a multicenter, open-label, randomized, parallel-group, non-inferiority clinical trial designed to evaluate whether avoiding graft recooling after normothermic machine perfusion (NMP) improves early outcomes following liver transplantation. Although graft recooling before implantation is common practice, experimental and preliminary clinical evidence suggests that abrupt temperature changes may contribute to ischemia-reperfusion injury.
Adult recipients of deceased-donor liver grafts preserved with NMP or sequential hypothermic-normothermic machine perfusion (SHNMP) will be randomized in a 1:1 ratio to either standard graft implantation with recooling using cold preservation solution (control group) or implantation without recooling using a room-temperature 5% albumin flush immediately before reperfusion (intervention group).
The primary objective is to compare the incidence of Early Allograft Dysfunction (EAD), defined according to the Olthoff criteria, between the two treatment groups. Secondary objectives include evaluation of histopathological ischemia-reperfusion injury using the Suzuki score, vascular and biliary complications, primary non-function, post-reperfusion syndrome, patient and graft survival, length of intensive care unit and hospital stay, perioperative transfusion requirements, and safety outcomes. A total of 170 participants will be enrolled across multiple Italian liver transplant centers and followed for 90 days after transplantation.
- Being tested
- No Recooling Before Liver Implantation, Traditional Recooling Before Liver Implantation
- Keywords
- Liver Transplantation, Normothermic Machine Perfusion, Ischemia-Reperfusion Injury, Early Allograft Dysfunction, Organ Preservation, Liver Graft
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Recooling Before Liver ImplantationProcedure or surgery
After completion of normothermic machine perfusion, the liver graft is flushed with 5% albumin solution at room temperature (20-25°C) and implanted without recooling. The graft remains at near-normothermic temperature throughout the transition from ex vivo perfusion to in situ implantation, avoiding the conventional cold preservation flush before reperfusion.
Traditional Recooling Before Liver ImplantationProcedure or surgery
After completion of normothermic machine perfusion, the liver graft undergoes the standard preservation procedure consisting of a cold preservation solution flush before implantation, resulting in graft recooling prior to reperfusion. The remainder of the transplantation procedure follows standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| No Recooling | Experimental | No Recooling Before Liver Implantation Receives: Procedure: No Recooling Before Liver Implantation |
| Traditional Recooling | Active comparator | Traditional Recooling Before Liver Implantation Receives: Procedure: Traditional Recooling Before Liver Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Allograft Dysfunction (EAD)
Incidence of Early Allograft Dysfunction (EAD), defined according to the Olthoff criteria as bilirubin ≥10 mg/dL or INR ≥1.6 on postoperative day 7, or AST/ALT >2000 IU/L within the first 7 postoperative days.
Measured: Within 7 days after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start7 Jul 2026 (estimated)
- Primary completion6 Oct 2028 (estimated)
- Study completion6 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplantation (LT)Studies 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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692490
- Sponsor's protocol ID
- IRRB/06/26
- Acronym
- ARANMP-LT
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation: a Multicenter, Parallel-group, Open-label, Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07692490
- Acronym / sponsor ID
- ARANMP-LT / IRRB/06/26
- Keywords
- Liver Transplantation, Normothermic Machine Perfusion, Ischemia-Reperfusion Injury, Early Allograft Dysfunction, Organ Preservation, Liver Graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized TherapiesUniversity, hospital or other
- Study start
- 7 Jul 2026 (estimated)
- Primary completion
- 6 Oct 2028 (estimated)
- Study completion
- 6 Oct 2028 (estimated)
- First posted
- 9 Jul 2026 (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.
The ARANMP-LT study is a multicenter, open-label, randomized, parallel-group, non-inferiority clinical trial designed to evaluate whether avoiding graft recooling after normothermic machine perfusion (NMP) improves early outcomes following liver transplantation. Although graft recooling before implantation is common practice, experimental and preliminary clinical evidence suggests that abrupt temperature changes may contribute to ischemia-reperfusion injury.
Adult recipients of deceased-donor liver grafts preserved with NMP or sequential hypothermic-normothermic machine perfusion (SHNMP) will be randomized in a 1:1 ratio to either standard graft implantation with recooling using cold preservation solution (control group) or implantation without recooling using a room-temperature 5% albumin flush immediately before reperfusion (intervention group).
The primary objective is to compare the incidence of Early Allograft Dysfunction (EAD), defined according to the Olthoff criteria, between the two treatment groups. Secondary objectives include evaluation of histopathological ischemia-reperfusion injury using the Suzuki score, vascular and biliary complications, primary non-function, post-reperfusion syndrome, patient and graft survival, length of intensive care unit and hospital stay, perioperative transfusion requirements, and safety outcomes. A total of 170 participants will be enrolled across multiple Italian liver transplant centers and followed for 90 days after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Recooling | Experimental | Procedure: No Recooling Before Liver ImplantationNo Recooling Before Liver Implantation |
| Traditional Recooling | Active comparator | Procedure: Traditional Recooling Before Liver ImplantationTraditional Recooling Before Liver Implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Listed for primary liver transplantation at the participating institution.
- Assigned a liver graft preserved with normothermic machine perfusion or sequential hypothermic- normothermic machine perfusion (SHNMP).
- Signed and dated informed consent prior study inclusion.
Key exclusion criteria (6 listed)
- Pediatric patients (age < 18 years)
- Patients undergoing re-transplantation (history of previous liver transplantation)
- Patients with acute liver failure
- Patients undergoing multi-organ transplantation (e.g., liver-kidney, liver-heart)
- Temporarily unconscious patients
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 |
|---|---|---|
| No Recooling Before Liver ImplantationAfter completion of normothermic machine perfusion, the liver graft is flushed with 5% albumin solution at room temperature (20-25°C) and implanted without recooling. The graft remains at near-normothermic temperature throughout the transition from ex vivo perfusion to in situ implantation, avoiding the conventional cold preservation flush before reperfusion. | Procedure or surgery | No Recooling |
| Traditional Recooling Before Liver ImplantationAfter completion of normothermic machine perfusion, the liver graft undergoes the standard preservation procedure consisting of a cold preservation solution flush before implantation, resulting in graft recooling prior to reperfusion. The remainder of the transplantation procedure follows standard clinical practice. | Procedure or surgery | Traditional Recooling |
Primary outcome
Early Allograft Dysfunction (EAD)
Time frame: Within 7 days after liver transplantation
Incidence of Early Allograft Dysfunction (EAD), defined according to the Olthoff criteria as bilirubin ≥10 mg/dL or INR ≥1.6 on postoperative day 7, or AST/ALT >2000 IU/L within the first 7 postoperative days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- 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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Recooling Before Liver Implantation and Traditional Recooling Before Liver Implantation in people with Liver Transplantation (LT) and Ischemia-Reperfusion Injury, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies at 14 sites 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Gruttadauria (0912192618 ext. +39 0912192618, sgruttadauria@ismett.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Allograft Dysfunction (EAD) (time frame: Within 7 days after liver transplantation). 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 14 Jul 2026.