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

NCT07421726 | Completed

• 1 other identifier: PERFEND
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transplant Patients; Organ Failure, Multiple; Organ Donor Registration

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitario di Bologna

Bologna, Bologna, 401328, Italy

Location

Related Publications (6)

• 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.

  PMID: 27495774 BACKGROUND

• 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.

  PMID: 34363412 BACKGROUND

• 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.

  PMID: 27050485 BACKGROUND

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

  PMID: 7482956 BACKGROUND

• 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.

  PMID: 30725140 BACKGROUND

• 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.

  PMID: 30725134 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

* liver/kidney biopsy * blood sampling * perfusate sampling * Urine sampling

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: February 19, 2026
• Study Start: March 17, 2025
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: February 19, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

IT (1)