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Transplant PatientsPERFENDNCT07421726

Controlled Terminal Reperfusion With Cold Preservation Solution in the cDCD III Donor

An observational study of Transplant Patients and Organ Failure, Multiple, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to describe the details of a controlled administration strategy of cold preservation solution or oxygenated cold preservation solution at the end of Abdominal Normothermic Regional Perfusion (A-NRP) in Controlled Donation afeter Circulatory determination of Death (cDCD) III… Read more about this study

Who is it for?
Ages 18 years and older
How many people
20 participants
Where
1 siteItaly
Study dates
17 Mar 2025to 16 Dec 2025
How long will I take part?
1 Year
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Donors belonging to the cDCD III category who have undergone A-NRP and liver or liver and kidney procurement for transplantation at one of the participating centers during the study period will be enrolled. At least one liver will subsequently be transplanted at the coordinating center. The study design includes two cohorts, one retrospective and one prospective. The retrospective cohort will include 10 donors belonging to the cDCD III category, whose organs were procured between January 2024 and December 2024. The prospective cohort will include all cDCD III donors who have undergone A-NRP and liver or liver and kidney procurement for transplantation at one of the participating centers from 01/01/2025 onwards and are eligible for the study, up to a number of 10 cases (20 cases overall).

Who may be able to join

  • Deceased donor screened for death according to category III cardiovascular criteria, according to the modified Maastricht classification, procured and subjected to Abdominal Normothermic Regional Perfusion (A-NRP);
  • Donor risk assessment as standard or negligible/acceptable non-standard risk, according to the nomenclature and guidelines of the National Transplant Center (risk definition is established by the CRT-ER, possibly after consulting with the national second opinion)

Who cannot join

  • Presence of absolute contraindications to organ donation;
  • Dissent to donation expressed during life;
  • Opposition by eligible family members unless specifically expressing their wishes;
  • Unacceptable risk according to the National Transplant Center (CNT) guidelines;
  • Lack of authorization from the Prosecutor's Office in cases where required;
  • Infeasibility of the controlled administration of cold preservation solution with or without oxygenation, in the judgment of the first operator and/or the perfusionist in charge.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS Azienda Ospedaliero-Universitario di Bologna

    Bologna, Bologna, 401328

Other trials in Italy

About this study

The goal of this observational study is to describe the details of a controlled administration strategy of cold preservation solution or oxygenated cold preservation solution at the end of Abdominal Normothermic Regional Perfusion (A-NRP) in Controlled Donation afeter Circulatory determination of Death (cDCD) III donors.

The main purpose is to:

develope a standardized protocol for this type of donor

Data collected from partecipants, deceased donors belonging to cDCD III category, willl be analysed through descriptive stastistics.

Medical subject headings
Multiple Organ Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Speed of administration of the preservation solution (mL/min)

    Measured: the expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data.

  2. Time required for administration of the preservation solution (h and min)

    Measured: the expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data.

  3. Occurence and type of mechanical complications (involving the extracorporeal circuit or the perfusion system in use) during controleld adminsitration of the preservation solution

    Measured: the expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data.

  4. Inability to perform reperfusion through the extracorporeal circuit and specific reasons

    Measured: The expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data.

Secondary outcomes (3)

  1. Partial pressure of O2 (mm Hg) in the perfusate measured during perfusion at the end of the first bag of preservation solution and at the end of the last bag of preservation solution

    Measured: 1 year and 3 months

  2. Partial pressure of O2 (mm Hg) in the perfusate at the start of Ex-vivo Machine Perfusion (EVMP)

    Measured: The expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data.

  3. Somatic regional oxygen saturation (rSO2) measured at the renal level during reperfusion

    This parameter will be measured using near-infrared spectroscopy (NIRS) technology in each donor where feasible, considering the possibility of placing the sensors on the skin at a point where the distance from the renal cortex is no greater than 3-4 cm (The distance between the cortex and the skin surface will be measured bilaterally using transcutaneous ultrasound, locating the point of least depth)

    Measured: The expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start17 Mar 2025
  3. Primary completion16 Dec 2025
  4. Study completion16 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
20 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07421726
Sponsor's protocol ID
PERFEND
Acronym
PERFEND
Status last verified
Nov 2025
First submitted
18 Nov 2025
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigator undertakes to make the study protocol and results public. To this end, the study will be registered on an Open Science platform. Any formal presentation or publication of data derived from this study should be considered a publication by the investigator. The data will be made available in anonymized form upon a reasoned request to the study's PI.

Publications

  • De Carlis L, De Carlis R, Lauterio A, Di Sandro S, Ferla F, Zanierato M. Sequential Use of Normothermic Regional Perfusion and Hypothermic Machine Perfusion in Donation After Cardiac Death Liver Transplantation With Extended Warm Ischemia Time. Transplantation. 2016 Oct;100(10):e101-2. doi: 10.1097/TP.0000000000001419. No abstract available.

    PubMed 27495774

  • Maroni L, Musa N, Ravaioli M, Dondossola DE, Germinario G, Sulpice L, Cescon M, Rossi GE, Boudjema K. Normothermic with or without hypothermic oxygenated perfusion for DCD before liver transplantation: European multicentric experience. Clin Transplant. 2021 Nov;35(11):e14448. doi: 10.1111/ctr.14448. Epub 2021 Sep 12.

    PubMed 34363412

  • Hessheimer AJ, Garcia-Valdecasas JC, Fondevila C. Abdominal regional in-situ perfusion in donation after circulatory determination of death donors. Curr Opin Organ Transplant. 2016 Jun;21(3):322-8. doi: 10.1097/MOT.0000000000000315.

    PubMed 27050485

  • Kootstra G, Daemen JH, Oomen AP. Categories of non-heart-beating donors. Transplant Proc. 1995 Oct;27(5):2893-4. No abstract available.

    PubMed 7482956

  • Manara A, Procaccio F, Dominguez-Gil B. Expanding the pool of deceased organ donors: the ICU and beyond. Intensive Care Med. 2019 Mar;45(3):357-360. doi: 10.1007/s00134-019-05546-9. Epub 2019 Feb 6. No abstract available.

    PubMed 30725140

  • Smith M, Dominguez-Gil B, Greer DM, Manara AR, Souter MJ. Organ donation after circulatory death: current status and future potential. Intensive Care Med. 2019 Mar;45(3):310-321. doi: 10.1007/s00134-019-05533-0. Epub 2019 Feb 6.

    PubMed 30725134

Questions about this trial

What is this clinical trial studying?

An observational study of Transplant Patients and Organ Failure, Multiple, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 2 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: finished, as of the sponsor's last update on 19 Feb 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speed of administration of the preservation solution (mL/min) (time frame: the expected duration of the study is 1 year and 3 months: one year will be dedicated to the prospective enrollement of category III cDCD donors and the collection of the retrospective data, 3 months to the processing and analysis of the study data.). The study lists 4 primary outcomes in all. 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 NCT07421726, which also lists 6 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 19 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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