NCT06717542

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2023Jan 2028

Study Start

First participant enrolled

January 17, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

December 5, 2024

Status Verified

November 1, 2024

Enrollment Period

4.5 years

First QC Date

December 1, 2024

Last Update Submit

December 1, 2024

Conditions

Hepatic TransplantationRejection; Transplant, Liver

Keywords

TransplantLiver

Outcome Measures

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.

    Within 24 months

Study Arms (2)

Organ donors

OTHER

organ donors (legally deceased, brain death or cardiac death)

Diagnostic Test: histochemical and immunohistochemical analysisDiagnostic Test: RT-PCR

Organ recipients

OTHER

Organ recipients

Diagnostic Test: histochemical and immunohistochemical analysisDiagnostic Test: RT-PCR

Interventions

histochemical and immunohistochemical analysisDIAGNOSTIC_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

Organ donorsOrgan recipients
RT-PCRDIAGNOSTIC_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 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).

Organ donorsOrgan recipients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For Donors:
  • Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.
  • HOPE performed on the liver graft prior to transplantation.
  • For Recipients:
  • Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.
  • Age greater than/equal to 18 years.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Rejection, Psychology

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

COVID-19 TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Francesco Vasuri, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francecso Vasuri, MD

CONTACT

0512143761francesco.vasuri2@unibo.it

Deborah Malvi, MD

CONTACT

0512143761deborah.malvi@aosp.bo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Two arm designed
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2024

First Posted

December 5, 2024

Study Start

January 17, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

December 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)