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Completed

NCT Number: NCT07421726

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

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.

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Key information

Conditions

Transplant Patients Multiple Organ Failure Organ Donor Registration Organ Failure, Multiple Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitario di Bologna

Bologna, 401328, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

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

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

    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.

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

    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.

Secondary outcomes

  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

    Time frame: 1 year and 3 months

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

    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.

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

    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.

    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)

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: PERFEND

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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