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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Recooling | Experimental | No Recooling Before Liver Implantation |
|
| Traditional Recooling | Active Comparator | Traditional Recooling Before Liver Implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Recooling Before Liver Implantation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 7 days after liver transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salvatore Gruttadauria | Contact | 0912192618 | +39 0912192618 | sgruttadauria@ismett.edu |
| Monica Rizzo | Contact | 0912192692 | +39 0912192692 | ufficioricerca@ismett.edu |
| Name | Affiliation | Role |
|---|---|---|
| Salvatore Gruttadauria | The Mediterranean Institute for Transplantation and Advanced Specialized Therapies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Politecnica delle Marche, AUO delle Marche | Ancona | 60126 | Italy |
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|
| Traditional Recooling Before Liver Implantation | Procedure | 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. |
|
| Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari - Ospedale Giovanni XXIII | Bari | 70124 | Italy |
|
| ASST Papa Giovanni XXIII | Bergamo | 24127 | Italy |
|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | 40138 | Italy |
|
| Ospedale Università Policlinico San Martino - IRCCS | Genova | 16132 | Italy |
|
| Università di Modena e Reggio Emilia | Modena | 41124 | Italy |
|
| Azienda Ospedale-Università di Padova | Padova | 35128 | Italy |
|
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56126 | Italy |
|
| Fondazione PTV - Policlinico Tor Vergata | Roma | 00133 | Italy |
|
| Azienda Ospedaliera San Camillo Forlanini | Roma | 00152 | Italy |
|
| Azienda Ospedaliero-Universitaria Policlinico Umberto I - Sapienza Università di Roma | Roma | 00161 | Italy |
|
| Fondazione Policlinico "Agostino Gemelli" IRCCS | Roma | 00168 | Italy |
|
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | 37126 | Italy |
|
| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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