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| ID | Type | Description | Link |
|---|---|---|---|
| RC-2022-2773274 | Other Grant/Funding Number | Ministero della Salute |
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Despite the good clinical results in terms of outcome with the application of HOPE prior to liver transplantation, very little is still known about the phenotypic and molecular changes that occur during perfusion/preservation during HOPE, particularly with regard to endothelial trophism and activation. Delving into these aspects would be very useful to allow personalised perfusion treatments in the future, thus improving the outcome of transplantation.
The primary aim of the study is the identification of specific 'endothelial signatures' (markers on tissue with immunohistochemistry and gene expression with RT-PCR) in liver grafts after HOPE treatment, predictive of transplant outcome. Interventional study without drug, including two cohorts of patients: (1) liver donors, on whom an allocation biopsy for organ quality will be performed (as standard of care); (2) liver recipients (from donors in cohort 1) on whom a study-specific biopsy will be performed as soon as the transplant has taken place (after vascular anastomoses with organ revascularisation). The study-specific biopsy constitutes the intervention of the study; patients will be treated according to the judgement of the physician and the information reported in the Technical Data Sheet of each product of any concomitant therapies administered according to clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Organ donors | Other | organ donors (legally deceased, brain death or cardiac death) |
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| Organ recipients | Other | Organ recipients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| histochemical and immunohistochemical analysis | Diagnostic Test | 2 µm sections will be cut from the paraffin blocks for histochemical and immunohistochemical (IHC) investigations. IHC will be performed with an automated stainer (Ventana/Roche®, Ventana Medical Systems, USA) for the endothelial markers CD34, ERG, Nestin and Caveolin-1 |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of specific '"endothelial signatures" | Main outcomes to assess the outcome of transplantation will be the percentage of early (PNF and EAD, within 1 week after transplantation) and late (rejection and complications) complications, as well as mortality among recipients within 24 months. | Within 24 months |
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Inclusion Criteria:
Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francecso Vasuri, MD | Contact | 0512143761 | francesco.vasuri2@unibo.it | |
| Deborah Malvi, MD | Contact | 0512143761 | deborah.malvi@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Vasuri, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000087123 | COVID-19 Nucleic Acid Testing |
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Two arm designed
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| RT-PCR | Diagnostic Test | Custom RT-PCR analyses will be performed manually for the transcripts (mRNA) of the ERG, Nestin, VEGFR and other genes, at the Pathology Anatomy lab hall. 18 (Prof. D'Errico). Total RNA will be extracted from the paraffin blocks with the RecoverAllâ„¢ Total Nucleic Acid Isolation kit (Invitrogen). Reverse Transcriptase will be performed with the High Capacity Reverse Transcription kit (Life Technologies), using the specific primers. Real-Time PCR will be performed with the CFX Connect Real-Time PCR Identification System (BioRad). |
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| D008919 | Investigative Techniques |