CompletedNot Applicable

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

Italy20 participantsStarted 2025-03-17

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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.

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

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

Inability to perform reperfusion through the extracorporeal circuit and specific reasons

Timeframe: 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.

Trial details

NCT IDNCT07421726

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-16

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