Tissue Analysis of Liver Grafts as a Predictor of Transplant Outcome.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
HOPE performed on the liver graft prior to transplantation.
Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.
Age greater than/equal to 18 years.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
histochemical and immunohistochemical analysis
Diagnostic test2 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
RT-PCR
Diagnostic testCustom 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 RecoverAll™ 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).
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Organ donorsOther 2 interventions
Group B: Organ recipientsOther 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 24 monthsSponsors and contacts
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Source ClinicalTrials.gov