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New protocol aims to improve organ preservation in deceased donors

NCT ID NCT07421726

Knowledge-focused Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This observational study looked at how a cold preservation solution is given to deceased organ donors after a special blood flow procedure. The goal was to create a standard way to do this. Researchers studied 20 donors to see how fast the solution was given, how long it took, and if there were any problems. This is not a treatment study but a step toward better organ preservation methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a standardized protocol for preserving organs from deceased donors, potentially improving transplant outcomes.
What could go wrong
This is a small observational study (20 participants) focused on procedure description, not treatment efficacy. Results may not generalize to all donor types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

20 people

The number who actually took part.

Started

Mar 2025

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

multiple organ dysfunction syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Organ donor registration Organ failure, multiple Transplant patients

Contacts and locations

Locations

  • IRCCS Azienda Ospedaliero-Universitario di Bologna

    Bologna, Bologna, 401328, Italy

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