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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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| Measure | Description | 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitario di Bologna | Bologna | Bologna | 401328 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27495774 | Background | 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. | |
| 34363412 |
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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.
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| ID | Term |
|---|---|
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
| 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. |
| 27050485 | 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. |
| 7482956 | Background | Kootstra G, Daemen JH, Oomen AP. Categories of non-heart-beating donors. Transplant Proc. 1995 Oct;27(5):2893-4. No abstract available. |
| 30725140 | 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. |
| 30725134 | 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. |