NCT04744389: DCDNet

Comparison of Hypothermic Versus Normothermic Ex-vivo Preservation.

Status unknown NA Last updated 26 July 2022

What this trial tests

NA trial testing Hypothermic Machine Perfusion in End Stage Liver DIsease in 60 participants. Status unknown.

Timeline

15 December 2020

Primary endpoint
30 September 2022

31 March 2023

Quick facts

Lead sponsor	Azienda Ospedaliero, Universitaria Pisana
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	15 December 2020
Primary completion	30 September 2022
Estimated completion	31 March 2023
Sites	1 location across Italy

Drugs / interventions tested

• Hypothermic Machine Perfusion
• Normothermic Machine Perfusion

Conditions studied

• End Stage Liver DIsease — all drugs for End Stage Liver DIsease →

Sponsor

Azienda Ospedaliero, Universitaria Pisana — full company profile →

Who can join

Adults 18 to 75, any sex, with End Stage Liver DIsease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study groups:

The study is a multicenter (Pisa and Milan), prospective, randomized study comparing D-HOPE (HMP) vs NMP in DCD and ECD-DBD (extended criteria brain-dead donors). Once a DCD or a DBD with extended criteria (ECD-DBD) meets the inclusion criteria, they are randomized as follow:

1. 20 liver grafts from DCD after normothermic regional perfusion (NRP) matching the inclusion criteria are randomized 1:1 to hypothermic machine perfusion (HMP) vs normothermic machine perfusion (NMP) and then transplanted.
2. 40 liver grafts from ECD-DBD matching the inclusion criteria are randomized 1:1 to hypothermic machine perfusion (HMP) vs normothermic machine perfusion (NMP) and then transplanted

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Machine perfusion in liver transplantation.
   Tingle SJ, Dobbins JJ, Thompson ER, Figueiredo RS, et al · · 2023 · cited 33× · PMID 37698189 · DOI 10.1002/14651858.cd014685.pub2
2. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation.
   Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, et al · · 2024 · cited 27× · PMID 38979743 · DOI 10.1002/14651858.cd011671.pub3
3. Perfusate Liver Arginase 1 Levels After End-Ischemic Machine Perfusion Are Associated with Early Allograft Dysfunction.
   Basta G, Babboni S, Pezzati D, Del Turco S, et al · · 2025 · cited 6× · PMID 39857827 · DOI 10.3390/biomedicines13010244
4. Machine perfusion of liver grafts: hypothermic versus normothermic versus normothermic regional perfusion.
   Patrono D, Del Prete L, Eden J, Dutkowski P, et al · · 2025 · cited 5× · PMID 40576122 · DOI 10.1097/js9.0000000000002648
5. Management of Normothermic Regional Perfusion Performance in Uncontrolled Versus Controlled Donation After Circulatory Death: A Multi-Center Investigation.
   Lazzeri C, Ghinolfi D, Bonizzoli M, Cultrera D, et al · · 2025 · PMID 41096133 · DOI 10.3390/jcm14197053
6. Improved Utilization Rate in Solid Organ Donors ≥80 Years: The 7-Year Tuscany Experience.
   Lazzeri C, Ghinolfi D, Santini LE, Procissi APO, et al · · 2025 · PMID 40145941 · DOI 10.1111/ctr.70142