---
title: Efficacy Evaluation of Normothermic Perfusion Machine Preservation in Liver Transplant Using Very Old Donors
nct_id: NCT02940600
overall_status: UNKNOWN
phase: NA
sponsor: Azienda Ospedaliero, Universitaria Pisana
study_type: INTERVENTIONAL
primary_condition: Ischemic Reperfusion Injury
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02940600.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02940600"
ct_last_update_post_date: 2016-10-21
last_seen_at: "2026-05-12T07:19:47.813Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy Evaluation of Normothermic Perfusion Machine Preservation in Liver Transplant Using Very Old Donors

**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

**NCT ID:** [NCT02940600](https://clinicaltrials.gov/study/NCT02940600)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Azienda Ospedaliero, Universitaria Pisana
- **Conditions:** Ischemic Reperfusion Injury
- **Start Date:** 2016-10
- **Completion Date:** 2018-10
- **CT.gov Last Update:** 2016-10-21

## Brief 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

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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
```

## Arms

- **Normothermic machine perfusion** (EXPERIMENTAL) — Patients undergoing liver transplant with grafts preserved using normothermic machine perfusion
- **Static cold storage** (ACTIVE_COMPARATOR) — Patients undergoing liver transplant with statically cold preserved grafts

## Interventions

- **Normothermic machine perfusion** (DEVICE) — Patients undergoing liver transplant with the use of grafts preserved with normothermic perfusion machine
- **Static cold storage** (PROCEDURE) — Patients undergoing liver transplant using statically cold preserved grafts

## Primary Outcomes

- **6 months graft survival** _(time frame: 180 days)_

## 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)_

## Locations (1)

- UO Chirurgia Epatica e del Trapianto di Fegato, Pisa, Pisa, Italy — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.uo chirurgia epatica e del trapianto di fegato|pisa|pisa|italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02940600.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02940600*  
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