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

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.

Study Overview

• Status: Completed
• Conditions: Transplant Patients; Organ Failure, Multiple; Organ Donor Registration

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 401328
      • IRCCS Azienda Ospedaliero-Universitario di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Speed of administration of the preservation solution (mL/min)	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)	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.
Occurence and type of mechanical complications (involving the extracorporeal circuit or the perfusion system in use) during controleld adminsitration of the preservation solution	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.
Inability to perform reperfusion through the extracorporeal circuit and specific reasons	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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		1 year and 3 months
Partial pressure of O2 (mm Hg) in the perfusate at the start of Ex-vivo Machine Perfusion (EVMP)		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.
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)	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.

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Actual): December 16, 2025
• Study Completion (Actual): December 16, 2025

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Pathological Conditions, Signs and Symptoms; Multiple Organ Failure
• Other Study ID Numbers: PERFEND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No